Diphenhydramine Hydrochloride

Product NDC: 0904-2056
11-digit product format: 009042056
Labeler code: 0904
Product ID: 0904-2056_4b432cbb-d3d9-2f88-e063-6294a90a7ed5
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Major Pharmaceuticals
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2009-01-02
Marketing end: 2027-12-31
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 50 mg/1
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 Hydrochloride

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
TC2D6JAD40	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1020477	Internal RxNorm lookup
1049909	Internal RxNorm lookup
1092422	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
04e70311-6412-4a20-84e3-f6e26d5f19ab	Available on FDA.report

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
0904-2056-61	Diphenhydramine Hydrochloride	10 in 1 BLISTER PACK	CAPSULE	10		17
0904-2056-61	Diphenhydramine Hydrochloride	10 in 1 BOX	CAPSULE	10		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-2056-61	EA - Each	0904-2056	0fb519f3-b1a4-4405-b123-7e6143128961	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	9
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	9
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	9
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	9
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	9
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	9
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	9
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	9
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	9
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	9
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	DIPHENHYDRAMINE HCL CAPSULE [CARDINAL HEALTH]	6
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	DIPHENHYDRAMINE HCL CAPSULE [CARDINAL HEALTH]	6
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	DIPHENHYDRAMINE HCL CAPSULE [CARDINAL HEALTH]	6
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DIPHENHYDRAMINE HCL CAPSULE [CARDINAL HEALTH]	6
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DIPHENHYDRAMINE HCL CAPSULE [CARDINAL HEALTH]	6
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DIPHENHYDRAMINE HCL CAPSULE [CARDINAL HEALTH]	6
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	DIPHENHYDRAMINE HCL CAPSULE [CARDINAL HEALTH]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DIPHENHYDRAMINE HCL CAPSULE [CARDINAL HEALTH]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-2056	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE BANOPHEN (DIPHENHYDRAMINE HCL) CAPSULE [MAJOR PHARMACEUTICALS]	15	Current NDC, Legacy NDC, 2 package rows	20250101_04e70311-6412-4a20-84e3-f6e26d5f19ab.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 1 of 191 · 3,814 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
COLTALIN-DM	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	FORTUNE PHARMACAL COMPANY LIMITED	33e1bec0-323b-40b7-809a-cb65a71ad0ce	2026-09-17	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Geiss, Destin & Dunn Inc.	1ea07a01-8779-48c2-a287-b7be866cce7b	2026-09-10	Warnings	Exact identifier application number: M012
Childrens Cold and Allergy Relief	BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Strategic Sourcing Services LLC	d64fe757-9948-4727-b5dd-1f8e4e4763e2	2026-09-10	Warnings	Exact identifier application number: M012
Cold and Flu HBP	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE	Kroger Company	fd41e4a4-330f-4409-8ba3-0b3bb6f45bca	2026-09-10	Warnings	Exact identifier application number: M012
Nighttime Sleep Aid Berry Flavor	DIPHENHYDRAMINE HYDROCHLORIDE	Raritan Pharmaceuticals Inc	303d7651-9c8f-4a14-9f2c-7181fa0f003e	2026-09-09	Warnings	Exact identifier application number: M012
DRx Choice Fruit Punch	GUAIFENESIN	Raritan Pharmaceuticals Inc	a19d7e1c-c04e-41c6-8af6-ecde96299216	2026-09-09	Warnings	Exact identifier application number: M012
Mucus Relief Cold Flu and Sore Throat Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Raritan Pharmaceuticals Inc	2cb3e17f-3858-4773-a53f-0860ae6ff1b9	2026-09-09	Warnings	Exact identifier application number: M012
MUCINEX FAST-MAX Liquid Gels Day Night Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	Reckitt Benckiser LLC	3856c1e4-814f-85c4-e063-6394a90ab8a8	2026-09-09	Warnings	Exact identifier application number: M012
DRx Choice Long Acting Cough	DEXTROMETHORPHAN HBR	RARITAN PHARMACEUTICALS	875b40bd-7955-4048-abbf-7f43d9ea3ac5	2026-09-09	Warnings	Exact identifier application number: M012
severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Rite Aid Corporation	4b8ae971-ab57-4937-a878-72d905d7b849	2026-09-09	Warnings	Exact identifier application number: M012
Cold and Flu Relief	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	82ba9a73-60ef-49fd-960f-5ca2bb79555e	2026-09-09	Warnings	Exact identifier application number: M012
Mucus Relief DM	DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN	The Kroger Co.	49829083-5c0a-4620-bfb3-7103642368db	2026-09-09	Warnings	Exact identifier application number: M012
DRx Choice Childrens Stuffy Nose and Chest Congestion	GUAIFENESIN AND PHENYLEPHRINE HCL	RARITAN PHARMACEUTICALS	7a3bb739-ff50-4d29-b270-d6b084906493	2026-09-09	Warnings	Exact identifier application number: M012
DRx Choice Children daytime Cough and Chest Congestion	DEXTROMETHORPHAN HBR AND GUAIFENESIN	RARITAN PHARMACEUTICALS	25fff2a6-ecb1-4117-bd11-e5ec3e3d09a9	2026-09-09	Warnings	Exact identifier application number: M012
Mucus Relief Severe Congestion and Cough Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Raritan Pharmaceuticals Inc	8a166067-b492-4742-b74c-28fac87c8d70	2026-09-09	Warnings	Exact identifier application number: M012
DRx Choice maximum strength Severe Cough plus sore throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	RARITAN PHARMACEUTICALS	a096cb76-0d1c-4ca8-854a-5199da0bc8f7	2026-09-09	Warnings	Exact identifier application number: M012
Vicks DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTION	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	The Procter & Gamble Manufacturing Company	efb69cc1-a745-6efc-e053-2a95a90abdc9	2026-09-08	Warnings	Exact identifier application number: M012
Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTION	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE	The Procter & Gamble Manufacturing Company	efb5f0b9-9825-ab23-e053-2995a90a26ab	2026-09-08	Warnings	Exact identifier application number: M012
Vicks DayQuil and Nyquil VapoCOOL Severe COLD and FLU plus CONGESTION	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE	The Procter & Gamble Manufacturing Company	f4328b44-cdfa-41aa-e053-2995a90a2728	2026-09-08	Warnings	Exact identifier application number: M012
Vicks childrens Cough Congestion	PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESIN	The Procter & Gamble Manufacturing Company	e2356457-9791-3710-e053-2995a90ad140	2026-09-08	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
1092422	BANOPHEN 25 MG Oral Capsule	PSN	04e70311-6412-4a20-84e3-f6e26d5f19ab	17
1049909	diphenhydrAMINE HCl 25 MG Oral Capsule	PSN	04e70311-6412-4a20-84e3-f6e26d5f19ab	17
1020477	diphenhydrAMINE HCl 50 MG Oral Capsule	PSN	04e70311-6412-4a20-84e3-f6e26d5f19ab	17
1092422	diphenhydramine hydrochloride 25 MG Oral Capsule [Banophen]	SBD	04e70311-6412-4a20-84e3-f6e26d5f19ab	17
1049909	diphenhydramine hydrochloride 25 MG Oral Capsule	SCD	04e70311-6412-4a20-84e3-f6e26d5f19ab	17
1020477	diphenhydramine hydrochloride 50 MG Oral Capsule	SCD	04e70311-6412-4a20-84e3-f6e26d5f19ab	17
1092422	Banophen 25 MG Oral Capsule	SY	04e70311-6412-4a20-84e3-f6e26d5f19ab	17
1020477	diphenhydramine HCl 50 MG Oral Capsule	SY	04e70311-6412-4a20-84e3-f6e26d5f19ab	17
1020477	diphenhydrAMINE HCl 50 MG Oral Capsule	PSN	abc0e348-8532-4658-bd8c-d7dbe5a28c7d	16
1020477	diphenhydramine hydrochloride 50 MG Oral Capsule	SCD	abc0e348-8532-4658-bd8c-d7dbe5a28c7d	16
1020477	diphenhydramine HCl 50 MG Oral Capsule	SY	abc0e348-8532-4658-bd8c-d7dbe5a28c7d	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-2056-61	00904205661	10 BLISTER PACK in 1 BOX (0904-2056-61) / 10 CAPSULE in 1 BLISTER PACK	10 blister pack	2009-01-02	2027-12-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
0835&0836	Cardinal Health 107, LLC	2026-04-23	HUMAN OTC DRUG LABEL	16
0835&0836(box unit)-Major	Major Pharmaceuticals	2026-02-20	HUMAN OTC DRUG LABEL	17
Diphenhydramine Hydrochloride - REMEDYREPACK INC.	REMEDYREPACK INC.	2017-11-22	HUMAN OTC DRUG LABEL	1