Banophen

Product NDC: 0904-5174
11-digit product format: 009045174
Labeler code: 0904
Product ID: 0904-5174_9362aa10-fbe0-0ce0-e053-2995a90a6186
Type: HUMAN OTC DRUG
Nonproprietary name: diphenhydramine hydrochloride
Dosage form: LIQUID
Route: ORAL
Labeler: Major Pharmaceuticals
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2012-08-24
Marketing end: 2020-10-31
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 13 mg/5mL
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0904-5174		D	Discontinued by firm		2026-10-05
excluded package	package	0904-5174	0904-5174-16	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0904-5174-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0904-5174-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0904-5174-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0904-5174-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0904-5174-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0904-5174-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0904-5174-16	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0904-5174-16	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0904-5174-16	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0904-5174-16	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0904-5174-16	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0904-5174-16	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-5174-16	ML - Milliliter	0904-5174	64f0a5e7-0bdc-4c50-ab4e-1a4f91cdbee8	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
diphenhydramine hydrochloride	ACTIVE INGREDIENT	TC2D6JAD40	BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [MAJOR PHARMACEUTICALS]	1
Diphenhydramine	ACTIVE MOIETY	8GTS82S83M	BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [MAJOR PHARMACEUTICALS]	1
Cherry	INACTIVE INGREDIENT	BUC5I9595W	BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [MAJOR PHARMACEUTICALS]	1
Citric Acid Monohydrate	INACTIVE INGREDIENT	2968PHW8QP	BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [MAJOR PHARMACEUTICALS]	1
D&C Red no. 33	INACTIVE INGREDIENT	9DBA0SBB0L	BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [MAJOR PHARMACEUTICALS]	1
FD&C Red no. 40	INACTIVE INGREDIENT	WZB9127XOA	BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [MAJOR PHARMACEUTICALS]	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [MAJOR PHARMACEUTICALS]	1
Polysorbate 20	INACTIVE INGREDIENT	7T1F30V5YH	BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [MAJOR PHARMACEUTICALS]	1
Saccharin Sodium Dihydrate	INACTIVE INGREDIENT	SB8ZUX40TY	BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [MAJOR PHARMACEUTICALS]	1
Sodium Benzoate	INACTIVE INGREDIENT	OJ245FE5EU	BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [MAJOR PHARMACEUTICALS]	1
Sodium Citrate	INACTIVE INGREDIENT	1Q73Q2JULR	BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [MAJOR PHARMACEUTICALS]	1
Sorbitol	INACTIVE INGREDIENT	506T60A25R	BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [MAJOR PHARMACEUTICALS]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [MAJOR PHARMACEUTICALS]	1

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
1092424	Banophen 12.5 MG in 5 mL Oral Solution	PSN	f60f923c-b2d6-4917-98cc-b0a8e3e47239	6
1049906	diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution	PSN	f60f923c-b2d6-4917-98cc-b0a8e3e47239	6
1092424	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution [Banophen]	SBD	f60f923c-b2d6-4917-98cc-b0a8e3e47239	6
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	f60f923c-b2d6-4917-98cc-b0a8e3e47239	6
1092424	Banophen 12.5 MG per 5 ML Oral Solution	SY	f60f923c-b2d6-4917-98cc-b0a8e3e47239	6
1092424	Banophen 2.5 MG/ML Oral Solution	SY	f60f923c-b2d6-4917-98cc-b0a8e3e47239	6
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	f60f923c-b2d6-4917-98cc-b0a8e3e47239	6
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	f60f923c-b2d6-4917-98cc-b0a8e3e47239	6
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	f60f923c-b2d6-4917-98cc-b0a8e3e47239	6

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Banophen™	Major Pharmaceuticals	2019-09-25	HUMAN OTC DRUG LABEL	4
Banophen	Atlantic Biologicals Corps	2019-09-17	HUMAN OTC DRUG LABEL	6
Banophen	ATLANTIC BIOLOGICALS CORP.	2017-03-10	HUMAN OTC DRUG LABEL	1