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 106 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Exchange Select Cough Drops Original Herb	MENTHOL	Army & Air Force Exchange Service	3d7109a5-4fe1-039b-e063-6394a90a1392	2025-08-28	Warnings	Exact identifier application number: M012
MGC Health Cough Drops Honey Herb	MENTHOL	Medical Group Care LLC	3d710deb-e42d-13eb-e063-6394a90a56e1	2025-08-28	Warnings	Exact identifier application number: M012
Sinus Relief Pressure and Pain	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Kroger Company	98de5cff-3ff5-49b0-bef9-5b9ebb86491e	2025-08-27	Warnings	Exact identifier application number: M012
Nighttime SEVERE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	H E B	0a178114-0748-4a92-9b60-a7a0a8b72287	2025-08-26	Warnings	Exact identifier application number: M012
Adult Bisolvine Adult	GUAIFENESIN, DEXTROMETHORPHAN	MENPER DISTRIBUTORS INC.	8cde5e39-a338-45af-b847-3823627f29c5	2025-08-25	Warnings	Exact identifier application number: M012
Pain Reliever PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Strategic Sourcing Services LLC	997eb228-09cb-47ad-acbb-363b05c67635	2025-08-25	Warnings	Exact identifier application number: M012
QUALITY CHOICE Childrens Allergy Relief DYE FREE	DIPHENHYDRAMINE HYDROCHLORIDE	QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)	644f39d8-7cd6-43dd-9265-546d01d32e8c	2025-08-22	Warnings	Exact identifier application number: M012
SanaTos Multi Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI	Pharmadel LLC	df260190-89e7-b338-e053-2995a90a32cb	2025-08-22	Warnings	Exact identifier application number: M012
Geri-Dryl allergy relief	DIPHENHYDRAMINE HCL	VerityRx	9ca6c0f8-71d1-4953-8e98-3311c4664011	2025-08-22	Warnings	Exact identifier application number: M012
SU PHEDRINE PE Non-Drowsy, Maximum Strength	PHENYLEPHRINE HCL	Salado Sales, Inc.	9056fa58-d6aa-4df5-97e0-9be3f2332f86	2025-08-22	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	MY IMPORTS USA LLC	3cde0c23-5c5c-9715-e063-6294a90a9462	2025-08-21	Warnings	Exact identifier application number: M012
Severe Cold Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS Pharmacy	258d27a9-fea6-4076-8dfa-77c7e982d250	2025-08-20	Warnings	Exact identifier application number: M012
MedPride Chest Rub	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	Shield Line LLC	85cd2fb8-d688-c3a3-e053-2991aa0ac18c	2025-08-20	Warnings	Exact identifier application number: M012
Adult Cough and Chest Congestion Relief DM Non Drowsy	DEXTROMETHORPHAN HBR, GUAIFENESIN	Safeway, Inc.	5bd508a0-2f75-413e-a690-bed970131bef	2025-08-19	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	BJWC (Berkley & Jensen / BJ's)	2f32d32e-e92c-ea57-e063-6394a90a4c39	2025-08-19	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Rite Aid Corporation	0eff2050-2d15-40cf-b96d-666d1dd83120	2025-08-19	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Non Drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Rite Aid Corporation	09bd88ec-ff84-4640-b561-243fda727043	2025-08-19	Warnings	Exact identifier application number: M012
Daytime Nighttime Sinus Relief Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL,GUAIFENESIN	CVS Pharmacy	1de2a7fd-129e-4b7b-a9bf-7a5811367bbf	2025-08-18	Warnings	Exact identifier application number: M012
Night Time Cold and Flu Relief Multi Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Rite Aid Corporation	28785677-2e80-4d6e-8997-bf5ac2ffb5a2	2025-08-18	Warnings	Exact identifier application number: M012
Daytime Mucus Relief Severe Cold and Nighttime Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL,GUAIFENESIN	CVS Pharmacy	2b7c5b5a-ebe3-4381-bb71-2359bc553df5	2025-08-18	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