Childrens Allergy Relief

Product NDC: 76281-301
11-digit product format: 762810301
Labeler code: 76281
Product ID: 76281-301_80d18641-4f89-4859-bdc0-ca7120be4d1c
Type: HUMAN OTC DRUG
Nonproprietary name: DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form: LIQUID
Route: ORAL
Labeler: AptaPharma Inc.
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2013-08-21
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	76281-301		I	Inactivated by FDA		2026-10-05
excluded package	package	76281-301	76281-301-24	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 · 36 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	76281-301-24	`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	76281-301-24	`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	76281-301-24	`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	76281-301-24	`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	76281-301-24	`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	76281-301-24	`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	76281-301-24	`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	76281-301-24	`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	76281-301-24	`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	76281-301-24	`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	76281-301-24	`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	76281-301-24	`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	76281-301-24	`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	76281-301-24	`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	76281-301-24	`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	76281-301-24	`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	76281-301-24	`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	76281-301-24	`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
76281-301-24	2022-01-28	C162847	48780-1	d6a99b39-50d1-a426-e053-dadaa90af4c2	ba3e2fd5-14d2-4fce-9de3-b0b9c1d2ee8f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76281-301-24	Childrens Allergy Relief	118 mL in 1 BOTTLE	LIQUID	118		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [APTAPHARMA INC.]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [APTAPHARMA INC.]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [APTAPHARMA INC.]	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [APTAPHARMA INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [APTAPHARMA INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [APTAPHARMA INC.]	1
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [APTAPHARMA INC.]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [APTAPHARMA INC.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [APTAPHARMA INC.]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [APTAPHARMA INC.]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [APTAPHARMA INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [APTAPHARMA INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76281-301	CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [APTAPHARMA INC.]	2	Legacy NDC, 1 package rows	20191029_ba3e2fd5-14d2-4fce-9de3-b0b9c1d2ee8f.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
1049906	diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution	PSN	ba3e2fd5-14d2-4fce-9de3-b0b9c1d2ee8f	2
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	ba3e2fd5-14d2-4fce-9de3-b0b9c1d2ee8f	2
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	ba3e2fd5-14d2-4fce-9de3-b0b9c1d2ee8f	2
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	ba3e2fd5-14d2-4fce-9de3-b0b9c1d2ee8f	2
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	ba3e2fd5-14d2-4fce-9de3-b0b9c1d2ee8f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76281-301-24	76281030124	118 mL in 1 BOTTLE (76281-301-24)	118 ml	2013-08-21	0000-00-00	No	No	Current