Banophen

Product NDC: 0904-5551
11-digit product format: 009045551
Labeler code: 0904
Product ID: 0904-5551_e0443532-ae16-498a-86f5-c706edb11aa6
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Major Pharmaceuticals
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1990-03-02
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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: Banophen
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	25 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1049630	Internal RxNorm lookup
1092421	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
69b7f7ca-7a3a-4fe6-a9bb-90b0e6ad62c1	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	SPL version
0904-5551-24	Banophen	12 in 1 BLISTER PACK	TABLET, FILM COATED	12	16
0904-5551-24	Banophen	2 in 1 CARTON	TABLET, FILM COATED	2	16
0904-5551-59	Banophen	1 in 1 CARTON	TABLET, FILM COATED	1	16
0904-5551-59	Banophen	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-5551-24	EA - Each	0904-5551	805dcd85-34b6-4a0a-9406-d46680925db8	1	2012-07-24
0904-5551-59	EA - Each	0904-5551	6037c229-d392-48f1-bbd8-febe968f67a3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [MAJOR PHARMACEUTICALS]	4
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [MAJOR PHARMACEUTICALS]	4
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [MAJOR PHARMACEUTICALS]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [MAJOR PHARMACEUTICALS]	4
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [MAJOR PHARMACEUTICALS]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [MAJOR PHARMACEUTICALS]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [MAJOR PHARMACEUTICALS]	4
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [MAJOR PHARMACEUTICALS]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [MAJOR PHARMACEUTICALS]	4
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [MAJOR PHARMACEUTICALS]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [MAJOR PHARMACEUTICALS]	4
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [CARILION MATERIALS MANAGEMENT]	2
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [CARILION MATERIALS MANAGEMENT]	2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [CARILION MATERIALS MANAGEMENT]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [CARILION MATERIALS MANAGEMENT]	2
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [CARILION MATERIALS MANAGEMENT]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [CARILION MATERIALS MANAGEMENT]	2
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [CARILION MATERIALS MANAGEMENT]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [CARILION MATERIALS MANAGEMENT]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [CARILION MATERIALS MANAGEMENT]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [CARILION MATERIALS MANAGEMENT]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-5551	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	15	Current NDC, Legacy NDC, 4 package rows	20241103_69b7f7ca-7a3a-4fe6-a9bb-90b0e6ad62c1.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 2 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Cold Multi-Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Wal-Mart Stores Inc	077fac1a-0ec5-40d9-8861-a281b48f650a	2026-09-08	Warnings	Exact identifier application number: M012
Overnight Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	RARITAN PHARMACEUTICALS	eef00453-9f4f-4a05-bb4e-49b94705b52c	2026-09-08	Warnings	Exact identifier application number: M012
Nighttime Severe Cold and Cough	ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE	RARITAN PHARMACEUTICALS INC	9819155b-2713-42be-867e-16605e7643d0	2026-09-08	Warnings	Exact identifier application number: M012
Cold and Flu HBP	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE	WALMART INC.	f9d1dfd1-527f-491d-9188-14886ac70ced	2026-09-08	Warnings	Exact identifier application number: M012
severe cold and cough daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	RARITAN PHARMACEUTICALS INC	3ce8508e-7d9d-4413-858a-8f952e760c01	2026-09-08	Warnings	Exact identifier application number: M012
Multi Symptom Severe Cold	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	RARITAN PHARMACEUTICALS INC	d9606c9a-31b1-4121-9870-809a05f5b68a	2026-09-08	Warnings	Exact identifier application number: M012
Mucus Relief DM Honey and Berry Flavor	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	RARITAN PHARMACEUTICALS INC	4898b1c2-55ef-4589-982b-2279c01707e5	2026-09-08	Warnings	Exact identifier application number: M012
Mucus Relief Severe Congestion and Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Chain Drug Marketing Association, Inc.	2a7afe03-3c34-4e30-827e-b3bb2568cb97	2026-09-08	Warnings	Exact identifier application number: M012
Drx Choice childrens allergy chews	DIPHENHYDRAMINE HCL	RARITAN PHARMACEUTICALS INC	dd2be906-bd0a-437c-9693-54b9391a5da3	2026-09-05	Warnings	Exact identifier application number: M012
Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Meijer Distribution, Inc.	49235f4f-e661-4a83-88ef-b9a956848777	2026-09-04	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HYDROCHLORIDE	Rite Aid Corporation	71845bf9-8981-4ca0-a62c-dbef102b1b02	2026-09-04	Warnings	Exact identifier application number: M012
NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Amazon.com Services LLC	774d2bde-9f57-4ced-800a-cada39c685ed	2026-09-04	Warnings	Exact identifier application number: M012
Nostrilla	OXYMETAZOLINE HYDROCHLORIDE	Insight Pharmaceuticals LLC	86217847-8e2b-48cc-b289-4987fd3aa7c3	2026-09-04	Warnings	Exact identifier application number: M012
tussin cough chest congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Rite Aid Corporation	86fc3723-5fc5-4de5-bd04-7774c2abe539	2026-09-04	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Topco Associates, LLC	ed576bf1-3949-423e-af2e-e4b1a3839b21	2026-09-04	Warnings	Exact identifier application number: M012
tussin nighttime cough	DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Rite Aid Corporation	80d51af8-3a7b-4d22-8d4f-df5f91913047	2026-09-04	Warnings	Exact identifier application number: M012
NO MORE NOSEBLEED	OXYMETAZOLINE HYDROCHLORIDE	DR. FRIEDMAN'S NO MORE NOSEBLEED KIT INC.	69d3f1fe-b476-4f84-8c5e-94957b74b46c	2026-09-04	Warnings	Exact identifier application number: M012
Ultra Fine Mist Sinus Relief	OXYMETAZOLINE HYDROCHLORIDE	DOLGENCORP, INC.	5f134840-2465-4585-a85d-08d746f76f7a	2026-09-03	Warnings	Exact identifier application number: M012
Daytime Nighttime Severe Cold and Flu Relief	ACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCI DOXYLAMINE SUCINATE	Family Dollar (FAMILY WELLNESS)	22918db6-9096-4eb8-a742-aaa2dd5c31da	2026-09-03	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
1092421	BANOPHEN 25 MG Oral Tablet	PSN	69b7f7ca-7a3a-4fe6-a9bb-90b0e6ad62c1	16
1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	69b7f7ca-7a3a-4fe6-a9bb-90b0e6ad62c1	16
1092421	diphenhydramine hydrochloride 25 MG Oral Tablet [Banophen]	SBD	69b7f7ca-7a3a-4fe6-a9bb-90b0e6ad62c1	16
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	69b7f7ca-7a3a-4fe6-a9bb-90b0e6ad62c1	16
1092421	Banophen 25 MG Oral Tablet	SY	69b7f7ca-7a3a-4fe6-a9bb-90b0e6ad62c1	16
1092421	BANOPHEN 25 MG Oral Tablet	PSN	e1b05e0c-3c61-4e2e-8e6c-ca1ed5bb93cd	5
1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	e1b05e0c-3c61-4e2e-8e6c-ca1ed5bb93cd	5
1092421	diphenhydramine hydrochloride 25 MG Oral Tablet [Banophen]	SBD	e1b05e0c-3c61-4e2e-8e6c-ca1ed5bb93cd	5
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	e1b05e0c-3c61-4e2e-8e6c-ca1ed5bb93cd	5
1092421	Banophen 25 MG Oral Tablet	SY	e1b05e0c-3c61-4e2e-8e6c-ca1ed5bb93cd	5
1092421	BANOPHEN 25 MG Oral Tablet	PSN	62934d0f-b23d-4c03-9d60-a7bad41f9b42	3
1092421	BANOPHEN 25 MG Oral Tablet	PSN	cb498f07-75fe-47d5-9620-f87405d168af	3
1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	62934d0f-b23d-4c03-9d60-a7bad41f9b42	3
1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	cb498f07-75fe-47d5-9620-f87405d168af	3
1092421	diphenhydramine hydrochloride 25 MG Oral Tablet [Banophen]	SBD	62934d0f-b23d-4c03-9d60-a7bad41f9b42	3
1092421	diphenhydramine hydrochloride 25 MG Oral Tablet [Banophen]	SBD	cb498f07-75fe-47d5-9620-f87405d168af	3
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	62934d0f-b23d-4c03-9d60-a7bad41f9b42	3
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	cb498f07-75fe-47d5-9620-f87405d168af	3
1092421	Banophen 25 MG Oral Tablet	SY	62934d0f-b23d-4c03-9d60-a7bad41f9b42	3
1092421	Banophen 25 MG Oral Tablet	SY	cb498f07-75fe-47d5-9620-f87405d168af	3
1092421	BANOPHEN 25 MG Oral Tablet	PSN	2cdbe7df-4c67-9b05-e063-6394a90a4699	1
1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	2cdbe7df-4c67-9b05-e063-6394a90a4699	1
1092421	diphenhydramine hydrochloride 25 MG Oral Tablet [Banophen]	SBD	2cdbe7df-4c67-9b05-e063-6394a90a4699	1
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	2cdbe7df-4c67-9b05-e063-6394a90a4699	1
1092421	Banophen 25 MG Oral Tablet	SY	2cdbe7df-4c67-9b05-e063-6394a90a4699	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-5551-24	00904555124	2 BLISTER PACK in 1 CARTON (0904-5551-24) / 12 TABLET, FILM COATED in 1 BLISTER PACK	2 blister pack	1990-03-02	0000-00-00	No	No	Current
0904-5551-59	00904555159	1 BOTTLE, PLASTIC in 1 CARTON (0904-5551-59) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC		1990-03-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rite Aid 44-329	Major Pharmaceuticals \| LNK International, Inc.	2025-10-27	HUMAN OTC DRUG LABEL	16
Diphenhydramine 25mg (Emergency Kits)	Health Department, Oklahoma State	2025-01-29	HUMAN PRESCRIPTION DRUG LABEL	1
Rite Aid 44-329	A-S Medication Solutions	2024-01-08	HUMAN OTC DRUG LABEL	5
Rite Aid 44-329	Proficient Rx LP	2023-12-01	HUMAN OTC DRUG LABEL	3
Rite Aid 44-329	REMEDYREPACK INC.	2022-06-09	HUMAN OTC DRUG LABEL	11
Rite Aid 44-329	Carilion Materials Management	2016-08-04	HUMAN OTC DRUG LABEL	3