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 110 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DG HEALTH COLD FLU RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Dolgencorp Inc	320e4f32-66aa-48be-9afd-fa2b2c217dc1	2025-07-14	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	BETTER LIVING BRANDS LLC.	f29da4ca-443d-7035-e053-2a95a90acab8	2025-07-14	Warnings	Exact identifier application number: M012
CVS PHARMACY MS Adult Severe Multi Symptom Cough Cold Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	CVS PHARMACY	cdc9af7c-3766-4573-9d95-bf217907b932	2025-07-11	Warnings	Exact identifier application number: M012
Health Smart Vaporizing Chest Rub	MENTHOL AND CAMPHOR AND EUCALYPTUS OIL	International Wholesale Inc	398fee3d-7d93-9dbc-e063-6294a90abdcc	2025-07-10	Warnings	Exact identifier application number: M012
HEADACHE RELIEF	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	Kroger Company	bbed29a1-3c52-3531-e053-2995a90a686c	2025-07-10	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS PHARMACY, INC	b765c82e-5021-4772-8647-c5ebc596bc0a	2025-07-10	Warnings	Exact identifier application number: M012
Sinus Pressure and Pain	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	c378acaf-389a-4afb-a4f0-e367a907a468	2025-07-10	Warnings	Exact identifier application number: M012
Nasal Decongestant Non-Drowsy	PSEUDOEPHEDRINE HCL	CVS Pharmacy	3330b077-dab7-45c6-acbb-0f91f2271232	2025-07-09	Warnings	Exact identifier application number: M012
ACTIDOGESIC DF	ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE	ACTIPHARMA, LLC	ff8e2565-bce3-4c06-a416-6e8f369f057f	2025-07-09	Warnings	Exact identifier application number: M012
ACTINEL	DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL	ACTIPHARMA, LLC	db0cb6ae-0a4d-4232-805a-f3f3a058261f	2025-07-08	Warnings	Exact identifier application number: M012
HALLS Extra Strong	MENTHOL	Mondelez Global LLC	396f93a9-8d2c-2f27-e063-6294a90ab344	2025-07-08	Warnings	Exact identifier application number: M012
ACTICON	DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIPHARMA, LLC	aea0335d-75e6-4a90-86a5-f197cf024a11	2025-07-08	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	P & L Development, LLC	0bb006f6-c360-4cd5-81e9-0776d99d79e8	2025-07-08	Warnings	Exact identifier application number: M012
childrens cold cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Meijer, Inc.	026e530f-e133-4f20-bac5-354fbb647c9e	2025-07-08	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS PHARMACY, INC	f59016f3-a8f8-4c95-9414-01440f0574d9	2025-07-08	Warnings	Exact identifier application number: M012
ACTINEL PEDIATRIC	DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL	ACTIPHARMA, LLC	6bb92d74-4893-40b8-af58-eb307155e876	2025-07-08	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Maximum Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	776b7c67-56c7-420c-82b2-9a176d998396	2025-07-08	Warnings	Exact identifier application number: M012
ACTICON	DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIPHARMA, LLC	847014ab-86ae-40c5-8e7f-f1ddea14f1b3	2025-07-08	Warnings	Exact identifier application number: M012
Mucus Relief	GUAIFENESIN 400 MG	Cabinet Health, Inc.	26a51b0e-039c-663c-e063-6394a90ad384	2025-07-07	Warnings	Exact identifier application number: M012
EZ Nite Sleep	DIPHENHYDRAMINE HCL	Safeway, Inc.	21a68c60-3005-43bb-8ec5-7982239c93f8	2025-07-07	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