diphenhydramine hydrochloride

Product NDC: 76457-002
11-digit product format: 764570002
Labeler code: 76457
Product ID: 76457-002_0b586170-9b5f-74dc-e063-6394a90aa09b
Type: HUMAN OTC DRUG
Nonproprietary name: DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: Simpex Pharma Pvt. Ltd
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-02-09
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: diphenhydramine hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
TC2D6JAD40	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1049630	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
82771f6a-8b3d-4ffa-8b35-09c2faf3582c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76457-002-00	diphenhydramine hydrochloride	100 in 1 BOTTLE	TABLET	100		5
76457-002-00	diphenhydramine hydrochloride	1 in 1 CARTON	TABLET	1		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	DIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]	1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	DIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	DIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	DIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	DIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	DIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	DIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76457-002	DIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]	5	Current NDC, Legacy NDC, 2 package rows	20231201_82771f6a-8b3d-4ffa-8b35-09c2faf3582c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 20 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Health Pharma USA LLC	319e84fd-4033-f5eb-e063-6394a90aa2f3	2026-06-27	Warnings	Exact identifier application number: M012
HyVee Cough Drops Menthol	MENTHOL	HY-VEE, INC	47a6f3c3-a6fa-dd61-e063-6394a90a4965	2026-06-26	Warnings	Exact identifier application number: M012
HyVee Cough Drops Cherry	MENTHOL	HY-VEE, INC	47a717e9-56b3-e771-e063-6394a90a5c17	2026-06-26	Warnings	Exact identifier application number: M012
Calmco Allergy Relief	DIPHENHYDRAMINE HCL	CalmCo LLC	5532fd37-cdd6-97ab-e063-6394a90a3c77	2026-06-26	Warnings	Exact identifier application number: M012
Dr Kids Allergy Relief	DIPHENHYDRAMINE HCL	CalmCo LLC	5533e705-b8d5-71cf-e063-6394a90a2010	2026-06-26	Warnings	Exact identifier application number: M012
Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE	HHH Pharmaceuticals	265f1ce7-160c-4dda-b2e0-b78d68f962bd	2026-06-26	Warnings	Exact identifier application number: M012
Allergy Relief	CHLORPHENIRAMINE MALEATE	Bryant Ranch Prepack	ee052b39-1658-4071-b081-5433c87b5e4a	2026-06-25	Warnings	Exact identifier application number: M012
Allergy Multi-Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL	DOLGENCORP, LLC	fae1499a-7029-4208-8436-4d330347b915	2026-06-25	Warnings	Exact identifier application number: M012
Sinus Pressure and Pain Maximum Strength	ACETAMINOPHEN, PHENYLEPHRINE HCL	DOLGENCORP, LLC	4fe8f124-ac80-40b4-8e1d-96709c459a4f	2026-06-25	Warnings	Exact identifier application number: M012
Allergy and Sinus Headache	ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	91268cd0-c151-4744-a715-a57af3f3a314	2026-06-25	Warnings	Exact identifier application number: M012
Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Meijer Distribution, Inc.	a3c4b9c3-bdb1-4f79-bee6-1bb6bec215ea	2026-06-24	Warnings	Exact identifier application number: M012
Cold and Flu Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	cb475e7f-aec1-415d-9770-07cce4e02c07	2026-06-24	Warnings	Exact identifier application number: M012
Broncolito Children	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Pharmadel LLC	509f5b72-9894-ef44-e063-6394a90a6d07	2026-06-23	Warnings	Exact identifier application number: M012
Neo-Synephrine Severe	PHENYLEPHRINE HYDROCHLORIDE	BF ASCHER AND CO INC	54edaff7-d241-dc90-e063-6294a90ac64d	2026-06-23	Warnings	Exact identifier application number: M012
AXIV Sinus Severe Ultra Fine Mist	OXYMETAZOLINE HYDROCHLORIDE.	VIVUNT PHARMA LLC	4b81abf9-3ea7-e996-e063-6394a90a71e8	2026-06-23	Warnings	Exact identifier application number: M012
AXIV Sinus OVERNIGHT	OXYMETAZOLINE HYDROCHLORIDE.	VIVUNT PHARMA LLC	54e03a63-f978-33d4-e063-6394a90a30f2	2026-06-23	Warnings	Exact identifier application number: M012
equaline daytime cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	9a199782-5d7e-449b-a86c-969746f0e96f	2026-06-23	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Walgreen Company	542b9861-8055-45f6-8cbf-9fe5cde1c4d9	2026-06-23	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	BIONPHARMA INC.	3c1953a1-32e9-6c81-e063-6294a90a9fa2	2026-06-22	Warnings	Exact identifier application number: M012
DAYTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	59db2573-7ebb-4cf9-bfe3-428929bb4eeb	2026-06-22	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	82771f6a-8b3d-4ffa-8b35-09c2faf3582c	5
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	82771f6a-8b3d-4ffa-8b35-09c2faf3582c	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76457-002-00	76457000200	1 BOTTLE in 1 CARTON (76457-002-00) / 100 TABLET in 1 BOTTLE	1 bottle	2018-02-09	0000-00-00	No	No	Current