Diphenhydramine HCl

Product NDC: 0904-6985
11-digit product format: 009046985
Labeler code: 0904
Product ID: 0904-6985_8e5db62b-075e-4ba2-a139-533be1166006
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl
Dosage form: SOLUTION
Route: ORAL
Labeler: Major Pharmaceuticals
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-08-27
Marketing end: 2027-05-31
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 12.5 mg/5mL
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
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 HCl

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg/5mL

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
0904-6985-16	Diphenhydramine HCl	473 mL in 1 BOTTLE, PLASTIC	SOLUTION	473		14
0904-6985-20	Diphenhydramine HCl	118 mL in 1 BOTTLE, PLASTIC	SOLUTION	118		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6985-16	ML - Milliliter	0904-6985	6611c1f7-9ef0-4355-bd81-45259ef3f28e	1	2019-10-07
0904-6985-20	ML - Milliliter	0904-6985	49dd2649-9d77-4191-9704-1731d6e24956	1	2020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-6985	DIPHENHYDRAMINE HCL SOLUTION [MAJOR PHARMACEUTICALS]	11	Current NDC, Legacy NDC, 2 package rows	20240805_93753885-6add-462c-9df8-b0a1b9ce36c9.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 121 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Bryant Ranch Prepack	f40bfdfc-1cb4-4604-9790-fb8d1d5173c6	2025-01-31	Warnings	Exact identifier application number: M012
NIGHTIME COLD AND FLU	NIGHTIME COLD AND FLU	TARGET CORP	9dee9b92-eac9-b07d-e053-2995a90a0602	2025-01-31	Warnings	Exact identifier application number: M012
Rugby Chest Congestion Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Bryant Ranch Prepack	7b23faa9-40c8-4cea-b9fb-487cce2664af	2025-01-31	Warnings	Exact identifier application number: M012
BENADRYL Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	224ba2a3-1a93-29c8-e063-6394a90a9bef	2025-01-30	Warnings	Exact identifier application number: M012
Extra Strength Nite-Time Pain Relief	430R WALGREENS ACETAMINOPHEN 500 MG,DIPHENHYDRAMINE HCL 25 MG TABLET	WALGREENS	c25cff5a-93f5-62aa-e053-2a95a90aa7b4	2025-01-30	Warnings	Exact identifier application number: M012
NIGHTTIME COLD AND FLU Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	WALGREENS	dbf5c814-4e69-13ac-e053-2a95a90a49a3	2025-01-30	Warnings	Exact identifier application number: M012
Mucus DM Fast Max Day Cold and Flu and Night Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL	WALGREENS	f3770976-de73-52b8-e053-2995a90aad4f	2025-01-30	Warnings	Exact identifier application number: M012
Dextromethorphan HBr and Guaifenesin Oral Solution	DEXTROMETHORPHAN HBR AND GUAIFENESIN ORAL SOLUTION	KESIN PHARMA CORPORATION	284eae44-81bc-400c-e063-6394a90af446	2025-01-30	Warnings	Exact identifier application number: M012
Vapor Shower	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	26c82bc3-5753-4d56-96a4-a3f9c8c267d0	2025-01-30	Warnings	Exact identifier application number: M012
Vapor Shower	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	8095b211-8ae7-44e5-b89a-b7f730e28d51	2025-01-30	Warnings	Exact identifier application number: M012
Vapor Shower	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	2cf2f35b-5d59-e3ff-e063-6294a90a9b45	2025-01-30	Warnings	Exact identifier application number: M012
Sinus Congestion and Pain Relief Non-Drowsy, Daytime	ACETAMINOPHEN AND PHENYLEPHRINE HCL	Rite Aid Corporation	8a0a8abf-0a41-44f8-8f4f-aec68a0fa0c5	2025-01-30	Warnings	Exact identifier application number: M012
Mucinex Childrens Mighty Chews Cold and Flu	ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE	RB Health (US) LLC	2ce20ab5-5f2d-1c97-e063-6394a90ad67b	2025-01-29	Warnings	Exact identifier application number: M012
Guaifenesin and Dextromethorphan	GUAIFENESIN AND DEXTROMETHORPHAN	Major Pharmaceuticals	97b137c9-0bec-409a-91f7-e298c296578b	2025-01-29	Warnings	Exact identifier application number: M012
Childrens Mucus and Cough Relief	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS	1dc17665-62ce-f7f5-e063-6294a90af851	2025-01-29	Warnings	Exact identifier application number: M012
UP AND UP NO DRIP NASAL	OXYMETAZOLINE HYDROCHLORIDE	Target Corporation	760d6d0f-00fc-40bc-858d-83a0827d139f	2025-01-29	Warnings	Exact identifier application number: M012
Guaifenesin and Dextromethorphan	GUAIFENESIN AND DEXTROMETHORPHAN	Major Pharmaceuticals	51e48201-bb62-4e89-85eb-e4a416f93522	2025-01-29	Warnings	Exact identifier application number: M012
Severe Congestion and Cough Max	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Best Choice	8c878e47-94f4-484f-bdd8-6d87ac2440d8	2025-01-28	Warnings	Exact identifier application number: M012
Cough and Cold Therapy	CAMPHOR, MENTHOL, EUCALYPTUS OIL	Everlaan Organics Inc	088be461-7afc-586a-e063-6294a90a700b	2025-01-27	Warnings	Exact identifier application number: M012
Cough and Cold Therapy For Kids	CAMPHOR, MENTHOL, EUCALYPTUS OIL	Everlaan Organics Inc	088df369-114c-db4f-e063-6394a90acfac	2025-01-27	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
1049906	diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution	PSN	93753885-6add-462c-9df8-b0a1b9ce36c9	14
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	93753885-6add-462c-9df8-b0a1b9ce36c9	14
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	93753885-6add-462c-9df8-b0a1b9ce36c9	14
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	93753885-6add-462c-9df8-b0a1b9ce36c9	14
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	93753885-6add-462c-9df8-b0a1b9ce36c9	14
1049906	diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution	PSN	fa12a5a8-bf2d-4991-9d54-9c519e8e04cd	5
1049906	diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution	PSN	d3f769d7-3cbb-4469-bff8-2015619ee115	5
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	fa12a5a8-bf2d-4991-9d54-9c519e8e04cd	5
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	d3f769d7-3cbb-4469-bff8-2015619ee115	5
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	d3f769d7-3cbb-4469-bff8-2015619ee115	5
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	fa12a5a8-bf2d-4991-9d54-9c519e8e04cd	5
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	d3f769d7-3cbb-4469-bff8-2015619ee115	5
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	fa12a5a8-bf2d-4991-9d54-9c519e8e04cd	5
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	d3f769d7-3cbb-4469-bff8-2015619ee115	5
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	fa12a5a8-bf2d-4991-9d54-9c519e8e04cd	5
1049906	diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution	PSN	ebf42e5e-df98-65e5-e053-2a95a90a7ac3	1
1049906	diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution	PSN	e2532bb9-5182-4017-92b2-e9ece60b4846	1
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	ebf42e5e-df98-65e5-e053-2a95a90a7ac3	1
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	e2532bb9-5182-4017-92b2-e9ece60b4846	1
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	ebf42e5e-df98-65e5-e053-2a95a90a7ac3	1
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	e2532bb9-5182-4017-92b2-e9ece60b4846	1
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	ebf42e5e-df98-65e5-e053-2a95a90a7ac3	1
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	e2532bb9-5182-4017-92b2-e9ece60b4846	1
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	ebf42e5e-df98-65e5-e053-2a95a90a7ac3	1
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	e2532bb9-5182-4017-92b2-e9ece60b4846	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6985-16	00904698516	473 mL in 1 BOTTLE, PLASTIC (0904-6985-16)	473 ml	2019-08-27	2027-04-30	No	No	Current
0904-6985-20	00904698520	118 mL in 1 BOTTLE, PLASTIC (0904-6985-20)	118 ml	2019-08-27	2027-05-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Major 44-015 Delisted	Major Pharmaceuticals \| LNK International, Inc.	2026-10-08	HUMAN OTC DRUG LABEL	16
Major 44-015-DSP	Preferred Pharmaceuticals Inc.	2026-04-06	HUMAN OTC DRUG LABEL	5
Major 44-015-DSP	A-S Medication Solutions	2024-01-04	HUMAN OTC DRUG LABEL	5
Major 44-015-DSP	NuCare Pharmaceuticals,Inc.	2022-10-26	HUMAN OTC DRUG LABEL	1
Major 44-015-DSP	REMEDYREPACK INC.	2021-10-25	HUMAN OTC DRUG LABEL	1
Major 44-015-DSP	ATLANTIC BIOLOGICALS CORP.	2021-04-21	HUMAN OTC DRUG LABEL	1