Correct Dose

Product NDC: 76103-004
11-digit product format: 761030004
Labeler code: 76103
Product ID: 76103-004_ba07fb8f-073f-4f5c-8961-3ba2877971a1
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine Hydrochloride
Dosage form: LIQUID
Route: ORAL
Labeler: BFS Pharma, Inc.
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2011-06-15
Marketing end: 0000-00-00
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 13 mg/5mL
NDC exclude flag: E
Listing certified through: 2017-12-31
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	76103-004		I	Inactivated by FDA		2026-10-05
excluded package	package	76103-004	76103-004-10	I	Inactivated by FDA		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 · 44 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	76103-004-10	`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	76103-004-10	`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	76103-004-10	`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	76103-004-10	`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	76103-004-10	`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	76103-004-10	`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	76103-004-10	`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	76103-004-10	`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	76103-004-10	`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	76103-004-10	`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	76103-004-10	`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	76103-004-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	76103-004-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	76103-004-10	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	76103-004-10	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	76103-004-10	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	76103-004-10	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	76103-004-10	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	76103-004-10	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	76103-004-10	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	76103-004-10	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	76103-004-10	`110d247fa046…`	`a55b01930146…`

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
76103-004-10	2019-10-29	C162847	48780-1	960f7f55-c758-8e05-e053-dbdaa90a074a	d8dd70ed-37e2-4c7c-9676-dcedf7e3d5cd

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76103-004-10	Correct Dose Childrens Allergy Relief	10 in 1 CARTON	LIQUID	10		1
76103-004-10	Correct Dose Childrens Allergy Relief	5 mL in 1 POUCH	LIQUID	5		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Diphenhydramine Hydrochloride	ACTIVE INGREDIENT	TC2D6JAD40	CORRECT DOSE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [BFS PHARMA, INC.]	1
Diphenhydramine	ACTIVE MOIETY	8GTS82S83M	CORRECT DOSE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [BFS PHARMA, INC.]	1
anhydrous citric acid	INACTIVE INGREDIENT	XF417D3PSL	CORRECT DOSE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [BFS PHARMA, INC.]	1
D&C red NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	CORRECT DOSE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [BFS PHARMA, INC.]	1
FD&C red NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CORRECT DOSE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [BFS PHARMA, INC.]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	CORRECT DOSE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [BFS PHARMA, INC.]	1
glycyrrhizin, ammoniated	INACTIVE INGREDIENT	3VRD35U26C	CORRECT DOSE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [BFS PHARMA, INC.]	1
poloxamer 407	INACTIVE INGREDIENT	TUF2IVW3M2	CORRECT DOSE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [BFS PHARMA, INC.]	1
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	CORRECT DOSE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [BFS PHARMA, INC.]	1
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	CORRECT DOSE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [BFS PHARMA, INC.]	1
sodium citrate	INACTIVE INGREDIENT	1Q73Q2JULR	CORRECT DOSE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [BFS PHARMA, INC.]	1
sucrose	INACTIVE INGREDIENT	C151H8M554	CORRECT DOSE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [BFS PHARMA, INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	CORRECT DOSE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [BFS PHARMA, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76103-004	CORRECT DOSE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [BFS PHARMA, INC.]	1	Legacy NDC, 2 package rows	20110615_d8dd70ed-37e2-4c7c-9676-dcedf7e3d5cd.zip

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
1112713	Correct Dose children's allergy relief 12.5 MG in 5 mL Oral Solution	PSN	d8dd70ed-37e2-4c7c-9676-dcedf7e3d5cd	1
1049906	diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution	PSN	d8dd70ed-37e2-4c7c-9676-dcedf7e3d5cd	1
1112713	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution [Correct Dose Childrens Allergy Relief]	SBD	d8dd70ed-37e2-4c7c-9676-dcedf7e3d5cd	1
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	d8dd70ed-37e2-4c7c-9676-dcedf7e3d5cd	1
1112713	Correct Dose Childrens Allergy Relief 12.5 MG per 5 ML Prefilled Spoon	SY	d8dd70ed-37e2-4c7c-9676-dcedf7e3d5cd	1
1112713	Correct Dose Childrens Allergy Relief 2.5 MG/ML Oral Solution	SY	d8dd70ed-37e2-4c7c-9676-dcedf7e3d5cd	1
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	d8dd70ed-37e2-4c7c-9676-dcedf7e3d5cd	1
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	d8dd70ed-37e2-4c7c-9676-dcedf7e3d5cd	1
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	d8dd70ed-37e2-4c7c-9676-dcedf7e3d5cd	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
76103-004-10	76103000410	10 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Correct Dose Childrens Allergy Relief - BFS Pharma, Inc.	BFS Pharma, Inc.	2011-05-25	HUMAN OTC DRUG LABEL	1