banophen

Product NDC: 0904-1228
11-digit product format: 009041228
Labeler code: 0904
Product ID: 0904-1228_93628989-ada6-97a5-e053-2995a90ab7e4
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl
Dosage form: LIQUID
Route: ORAL
Labeler: Major Pharmaceuticals
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2006-11-20
Marketing end: 0000-00-00
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 13 mg/5mL
NDC exclude flag: No
Listing certified through: 2020-12-31
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	0904-1228		D	Discontinued by firm		2026-10-05
excluded package	package	0904-1228	0904-1228-20	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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0904-1228-20	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0904-1228-20	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0904-1228-20	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0904-1228-20	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0904-1228-20	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0904-1228-20	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0904-1228-20	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0904-1228-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0904-1228-20	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0904-1228-20	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0904-1228-20	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0904-1228-20	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0904-1228-20	2024-11-05	C162847	48780-1	d6a99b39-84ef-a426-e053-dadaa90af4c2	Banophen™ Allergy
0904-1228-20	2022-01-28	C162847	48780-1	d6a99b39-84ef-a426-e053-dadaa90af4c2	Banophen™ Allergy

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-1228-00	ML - Milliliter	0904-1228	119a2b62-49ae-4889-bdd5-72f6b7253d5a	1	2015-01-05
0904-1228-20	ML - Milliliter	0904-1228	e6ecd9ea-596b-49fb-9372-e4b7a497c9ff	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 HCL) LIQUID [MAJOR PHARMACEUTICALS]	2
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	BANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [MAJOR PHARMACEUTICALS]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	BANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [MAJOR PHARMACEUTICALS]	2
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	BANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [MAJOR PHARMACEUTICALS]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	BANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [MAJOR PHARMACEUTICALS]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [MAJOR PHARMACEUTICALS]	2
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	BANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [MAJOR PHARMACEUTICALS]	2
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	BANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [MAJOR PHARMACEUTICALS]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	BANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [MAJOR PHARMACEUTICALS]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	BANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [MAJOR PHARMACEUTICALS]	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	BANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [MAJOR PHARMACEUTICALS]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	BANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [MAJOR PHARMACEUTICALS]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	BANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [MAJOR PHARMACEUTICALS]	2
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	BANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [PROFICIENT RX LP]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	BANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [PROFICIENT RX LP]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	BANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [PROFICIENT RX LP]	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	BANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [PROFICIENT RX LP]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	BANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [PROFICIENT RX LP]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [PROFICIENT RX LP]	1
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	BANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [PROFICIENT RX LP]	1
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	BANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [PROFICIENT RX LP]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	BANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [PROFICIENT RX LP]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	BANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [PROFICIENT RX LP]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	BANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [PROFICIENT RX LP]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	BANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [PROFICIENT RX LP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	BANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [PROFICIENT RX LP]	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	bbe3f9ed-b3b0-4d05-bcaf-6c810a65773e	3
1049906	diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution	PSN	bbe3f9ed-b3b0-4d05-bcaf-6c810a65773e	3
1092424	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution [Banophen]	SBD	bbe3f9ed-b3b0-4d05-bcaf-6c810a65773e	3
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	bbe3f9ed-b3b0-4d05-bcaf-6c810a65773e	3
1092424	Banophen 12.5 MG per 5 ML Oral Solution	SY	bbe3f9ed-b3b0-4d05-bcaf-6c810a65773e	3
1092424	Banophen 2.5 MG/ML Oral Solution	SY	bbe3f9ed-b3b0-4d05-bcaf-6c810a65773e	3
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	bbe3f9ed-b3b0-4d05-bcaf-6c810a65773e	3
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	bbe3f9ed-b3b0-4d05-bcaf-6c810a65773e	3
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	bbe3f9ed-b3b0-4d05-bcaf-6c810a65773e	3

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Banophen™ Drug Facts	Proficient Rx LP	2024-01-01	HUMAN OTC DRUG LABEL	5
Banophen™ Allergy	Major Pharmaceuticals	2019-09-25	HUMAN OTC DRUG LABEL	5
Banophen™ Allergy	A-S Medication Solutions	2019-02-01	HUMAN OTC DRUG LABEL	3
Major Pharmaceuticals Banophen™ Drug Facts	NuCare Pharmaceuticals,Inc.	2017-07-21	HUMAN OTC DRUG LABEL	1