Is Diphenhydramine HCl safe in cosmetics?
Diphenhydramine HCl has a safety rating of "POOR" in our database. EU status: prohibited. US status: permitted.
Poor
Cosmetic Ingredient
Diphenhydramine HCl
Also known as: Ethanamine, 2-(diphenylmethoxy)-N,N-dimethyl-, hydrochloride, Difenhydramine hydrochloride, Ethanamine, 2-(diphenylmethoxy)-N,N-dimethyl-, hydrochloride (1:1), Ambenyl, Bendylate (+14 more)
INCI: DIPHENHYDRAMINE HCL
Diphenhydramine HCl (CAS 147-24-0) is a cosmetic cosmetic ingredient functioning as Skin-conditioning agent (pharmacologically active antihistamine). EU Regulation 1223/2009 status: prohibited. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.
View industrial chemical safety profile for CAS 147-24-0 →
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
Diphenhydramine HCl is prohibited in EU cosmetics but has active industrial GHS classifications (H302, H361, H362, H370, H372, H373).
Source: Cosmetics: ingredients.eu_status; Chemicals: ghs_classifications.signal_word/hazard_statement_code
Function
Skin-conditioning agent (pharmacologically active antihistamine)
Safety Rating
POOR
Chemistry & Identifiers
IUPAC Name
2-benzhydryloxy-N,N-dimethylethanamine;hydrochloride
InChIKey
PCHPORCSPXIHLZ-UHFFFAOYSA-N
Regulatory Status
EU EU Status
prohibited
US US Status
permitted
US Notes
Permitted — FDA permits as OTC active (antiemetic, sleep-aid, antihistamine); CIR deferred to FDA review
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Diphenhydramine HCl.
Calculate MoS for your specific formulation with the MoS Calculator.
HRIPT Human Patch Test Studies
1 human repeat insult patch test aggregated from dermatological literature.
| Test Type | N | Sensitized | Dose µg/cm² | NESIL µg/cm² | Potency |
|---|---|---|---|---|---|
| HMT | - | 0 | 15517.24 | - | - |
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Safety (1)
Carcinogen Classification
Diphenhydramine Hydrochloride | TR-355: Toxicology and Carcinogenesis Studies of Diphenhydramine Hydrochloride (CASRN 147-24-0) in F344/N Rats and B6C3F1 Mice (Feed Studies) (1989 ) | 10/03/88 | Equivocal Evidence | Equivocal Evidence | No Evidence | No Evidence | Under the conditions of these 2-year feed studies, there was equivocal evidence of carcinogenic activity of diphenhydramine hy
Source: NTP Technical Reports
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Pharmaceutical
Softener and conditioner
Expert Verdict
Expert safety assessment and concern-level summary for Diphenhydramine HCl.
Known Synonyms
Ethanamine, 2-(diphenylmethoxy)-N,N-dimethyl-, hydrochloride
Difenhydramine hydrochloride
Ethanamine, 2-(diphenylmethoxy)-N,N-dimethyl-, hydrochloride (1:1)
Ambenyl
Bendylate
Benzantin hydrochloride
Benzhydrol, beta-dimethylaminoethyl ether hydrochloride
Carphenamine
Carphenex
Cathejell
Dimedrolum
beta-Dimethylaminoethyl benzhydryl ether hydrochloride
Diphamine
Diphenylhydramine hydrochloride
2-(Diphenylmethoxy)-N,N-dimethylethylamine hydrochloride
Dobacen hydrochloride
EINECS 205-687-2
Eldadryl
NCI-C56075
Chemical Function
Softener and conditioner
Pharmaceutical
Regulatory Lists
detected; MN Chemical Screening; surface_water
active_ingredient; Australia
Canada; Personal care; Substances in PCP - Canada (4/2014)
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Compound
DIPHENHYDRAMINE HYDROCHLORIDE
ChEMBL ID
CHEMBL1620
Max Phase
4
Adverse Event Associations
9
Frequently Asked Questions
Is Diphenhydramine HCl allowed in the EU?
Diphenhydramine HCl EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.
What does Diphenhydramine HCl do in cosmetics?
Diphenhydramine HCl functions as: Skin-conditioning agent (pharmacologically active antihistamine). It is classified as a cosmetic ingredient in our database. CAS number: 147-24-0.
Is Diphenhydramine HCl used outside cosmetics?
Diphenhydramine HCl also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Does Diphenhydramine HCl have different safety status in cosmetics vs industrial chemicals?
Diphenhydramine HCl is prohibited in EU cosmetics but has active industrial GHS classifications (H302, H361, H362, H370, H372, H373).
Compliance Tools
Check Diphenhydramine HCl compliance across multiple jurisdictions:
Ingredient Decoder
Paste a full ingredient list for instant analysis
82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
Check compliance across multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
Compare limits across jurisdictions
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