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 146 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cold Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Harris Teeter	c92b508b-e5f9-4149-8c4b-d21845943b3b	2024-10-22	Warnings	Exact identifier application number: M012
Cold Flu Severe Day Night	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Harris Teeter	2924a691-b352-4263-b6ba-9ab97e95e2a5	2024-10-22	Warnings	Exact identifier application number: M012
Mucus Relief Cold and Flu All in One	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	HARRIS TEETER	b2091281-a64a-190a-e053-2995a90a890a	2024-10-22	Warnings	Exact identifier application number: M012
tussin	DEXTROMETHORPHAN HBR, GUAIFENESIN	Safeway	cf04bdf7-fed4-4f06-a193-f2e83fcc531c	2024-10-22	Warnings	Exact identifier application number: M012
Tukol Honey Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Genomma Lab USA	c9572b16-8e28-4f98-bd87-8a07721a49c6	2024-10-21	Warnings	Exact identifier application number: M012
Tukol Honey Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	Genomma Lab USA	bf25f38e-3549-4f78-be90-46605b5f2c11	2024-10-21	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	HEB	b5a6719e-746b-58ec-e053-2a95a90af010	2024-10-21	Warnings	Exact identifier application number: M012
Allergy Multi Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	HEB	a6cdc084-c23b-e733-e053-2995a90a3506	2024-10-21	Warnings	Exact identifier application number: M012
Cold Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	HEB	ea39a67d-8a99-4f7c-9925-94b07d0b1092	2024-10-21	Warnings	Exact identifier application number: M012
Head Congestion plus Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	HEB	eb7920a3-3c25-6aa1-e053-2995a90ac2b9	2024-10-21	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Severe Congestion Relief	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	HEB	9cbb3ab1-5f32-421e-9f28-d99be9447e9f	2024-10-21	Warnings	Exact identifier application number: M012
Head Congestion plus Mucus PE	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	HEB	eb791902-e2c3-5662-e053-2995a90a37fd	2024-10-21	Warnings	Exact identifier application number: M012
Cold Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	HEB	c3849b66-697f-4f6e-93ab-76de031b3c70	2024-10-21	Warnings	Exact identifier application number: M012
Cold Flu Severe Day Night	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	HEB	ee1477ed-00c4-46ea-bc57-aef214076dc2	2024-10-21	Warnings	Exact identifier application number: M012
DAYTIME SEVERE COLD AND FLU MAXIMUM STRENGTH	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	HEB	774e8bee-1ab5-4587-82e4-31da8ec83544	2024-10-21	Warnings	Exact identifier application number: M012
Mucus Relief Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	HEB	b1ba8ade-3441-f243-e053-2995a90a1230	2024-10-21	Warnings	Exact identifier application number: M012
Mucus Relief Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	HEB	b1ba22ac-c38d-a42e-e053-2995a90a6900	2024-10-21	Warnings	Exact identifier application number: M012
Diphenhydramine HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	25034563-6422-daf6-e063-6394a90af980	2024-10-21	Warnings	Exact identifier application number: M012
Childrens Allergy Relief Dye Free	DIPHENHYDRAMINE HCL	CARDINAL HEALTH 110, LLC. DBA LEADER	198add5f-20b7-75b0-e063-6394a90a6bd4	2024-10-21	Warnings	Exact identifier application number: M012
Tukol Honey Children Cough and Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Genomma Lab USA	dae33df8-2294-4242-a25b-2d89d1f63b23	2024-10-18	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