Diphenhydramine Hydrochloride

Product NDC: 0904-2056
Requested package NDC: 0904-2056-61
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

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 194 · 3,880 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Family Dollar Services Inc	ce590997-3cae-4f22-ac39-2b14d39494bc	2026-07-30	Warnings	Exact identifier application number: M012
Robitussin Direct Cough	DEXTROMETHORPHAN HYDROBROMIDE	Haleon US Holdings LLC	70c9556b-063a-4fb3-96f6-1d4ffa495ed4	2026-07-30	Warnings	Exact identifier application number: M012
Major Nasal Decongestant	OXYMETAZOLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	a302e341-1c00-4c3d-b71f-c4c0b307aa67	2026-07-29	Warnings	Exact identifier application number: M012
Pain Reliever PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Walgreens	4c737cd6-fe56-4cef-887c-cd6cf83b254c	2026-07-29	Warnings	Exact identifier application number: M012
ROBITUSSIN LONG-ACTING COUGHGELS	DEXTROMETHORPHAN HYDROBROMIDE	Haleon US Holdings LLC	472c5c1f-eb5a-444b-a17e-f0d71007fb15	2026-07-29	Warnings	Exact identifier application number: M012
DAYTIME COLD AND FLU NITETIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Meijer Distribution Inc	3a33c6ce-aada-4099-8c61-49c86c0fc1a8	2026-07-29	Warnings	Exact identifier application number: M012
Tussin DM Max Nighttime	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Wal-Mart Stores Inc	668c92ce-6c1f-4ab3-b0dd-822b0768cb5e	2026-07-29	Warnings	Exact identifier application number: M012
Benadryl	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	702f9786-7ce9-43e4-921d-e1db09612127	2026-07-28	Warnings	Exact identifier application number: M012
LoHist-D	CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL	Larken Laboratories, Inc.	efaa354e-c25c-405b-9d30-001c2796978c	2026-07-28	Warnings	Exact identifier application number: M012
NIGHTTIME SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	d1115a55-35cd-4f20-8872-f42983a5ebcd	2026-07-28	Warnings	Exact identifier application number: M012
TUSSIN	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Safeway	a5e2bda4-2da6-4c20-855d-2888dadf0c3a	2026-07-28	Warnings	Exact identifier application number: M012
DM Maximum	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	f6029b04-e681-40fc-be4f-14091b76dd4e	2026-07-27	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	CVS PHARMACY	e958eef1-8aae-4365-ac64-95a9e8e7e0f2	2026-07-27	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	DOLGENCORP INC	38400854-27fa-e291-e063-6294a90a5c4e	2026-07-27	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Better Living Brands, LLC	65802aa7-64e7-4435-ad6b-65895fba17ce	2026-07-27	Warnings	Exact identifier application number: M012
Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL	Walgreen Company	0a48f650-ad2a-4105-9ff4-2bc4d94b46d3	2026-07-27	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	84202ebe-97b6-4be2-bb09-7f2729303f96	2026-07-27	Warnings	Exact identifier application number: M012
Daytime Severe Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Rite Aid Corporation	8d41defe-8120-4cbb-b42e-c805cc5a794b	2026-07-24	Warnings	Exact identifier application number: M012
Childrens Benadryl ALLERGY	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	fc9181b9-c92d-493e-8d7c-4a4239c6c092	2026-07-24	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE	Prodose, Inc.	3afc88c7-388a-dbd9-e063-6294a90a4faf	2026-07-24	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