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 174 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MUCOSA	GUAIFENESIN	TIME CAP LABORATORIES,INC	d34ef2e8-adc2-48e5-a572-e354937daec6	2023-11-02	Warnings	Exact identifier application number: M012
Daytime Severe and Nighttime Severe cold and flu	DAYTIME SEVERE - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN AND NIGHTTIME SEVERE-ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	TARGET CORPORATION	09286d15-b63f-a9de-e063-6294a90ab948	2023-11-02	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	AMERIFOODS TRADING COMPANY	f6cece6c-23e4-7811-e053-6394a90a106a	2023-11-02	Warnings	Exact identifier application number: M012
Sinus Pressure plus Pain PE	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	eb64750f-19ac-655f-e053-2995a90a33b5	2023-11-02	Warnings	Exact identifier application number: M012
Multi-Symptom Mapap Cold Formula	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Proficient Rx LP	9bf81b26-38b4-486c-ae89-222119ce1a4f	2023-11-01	Warnings	Exact identifier application number: M012
Guaifenesin Syrup and Dextromethorphan	GUAIFENESIN SYRUP AND DEXTROMETHORPHAN	Natco Pharma USA LLC	ad9026f4-f0b6-4d02-aa44-f0460eeefc0e	2023-11-01	Warnings	Exact identifier application number: M012
Diphenhydramine HCl Oral Solution	DIPHENHYDRAMINE HYDROCHLORIDE	Natco Pharma USA LLC	54b64354-ac10-42ff-a53d-96cef933a91a	2023-11-01	Warnings	Exact identifier application number: M012
children allergy relief dye free cherry	DIPHENHYDRAMINE HCL	A-S Medication Solutions	5c6c1809-4c6f-4e8f-a5ae-9796e821d400	2023-11-01	Warnings	Exact identifier application number: M012
Daytime and Nighttime Cherry Cold and Flu	DAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE	TARGET CORPORATION	0903b222-1a44-64aa-e063-6294a90abba0	2023-10-31	Warnings	Exact identifier application number: M012
Ephrine Nose Drops	PHENYLEPHRINE HYDROCHLORIDE	Walgreens	b620eb9f-2caf-0942-e053-2a95a90ae48e	2023-10-31	Warnings	Exact identifier application number: M012
pseudoephedrine hydrochloride	PSEUDOEPHEDRINE HCL	A-S Medication Solutions	204849d1-ac4b-4dbe-8769-fcb30291f880	2023-10-31	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Relief	DAYTIME COLD AND FLU RELIEF	TopCo Associates, LLC	d592fbb8-d4bf-444e-982e-edf6fe97dce4	2023-10-31	Warnings	Exact identifier application number: M012
Nite Time Cold and Flu Relief	NITE TIME COLD AND FLU RELIEF	TopCo Associates, LLC	407dc4ae-882d-4a49-8884-ef048bb404cf	2023-10-31	Warnings	Exact identifier application number: M012
12 Hour Original Nasal Decongestant	NASAL SPRAY	Sheffield Pharmaceuticals LLC	cea0ce76-ae75-4484-a7c2-ff1086e9d8b0	2023-10-30	Warnings	Exact identifier application number: M012
Mucosa DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Magno-Humphries, Inc.	3a5533fb-1c83-4b95-9cd2-9be663d3ff5f	2023-10-27	Warnings	Exact identifier application number: M012
Mucosa Guifenesin	GUAIFENESIN	Magno-Humphries, Inc.	9d22c208-d0ae-8b6a-e053-2995a90ab90a	2023-10-27	Warnings	Exact identifier application number: M012
DG Health Cough Drops Cherry Flavor	MENTHOL	Dollar General Corporation	c7a603d8-72fb-9626-e053-2995a90a09ea	2023-10-26	Warnings	Exact identifier application number: M012
Allergy Relief 4 Hour	CHLORPHENIRAMINE MALEATE	Geri-Care Pharmaceutical Corp	92d90b41-0627-121e-e053-2995a90a2df1	2023-10-26	Warnings	Exact identifier application number: M012
Freegells Cough Drops Menthol Cherry	MENTHOL	Riclan S.A.	8e471265-3594-451a-8921-f0db474abe85	2023-10-26	Warnings	Exact identifier application number: M012
Freegells Cough Drops Menthol Eucalyptus	MENTHOL	Riclan S.A.	1141593a-f3ba-4adf-b332-f9fcb0b5a013	2023-10-26	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