Childrens Allergy Relief

Product NDC: 73282-0125
Requested package NDC: 73282-0125-1
11-digit product format: 732820125
Labeler code: 73282
Product ID: 73282-0125_e8450607-a68d-4729-e053-2995a90a2238
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine 12.5mg/5mL
Dosage form: SOLUTION
Route: ORAL
Labeler: CalmCo LLC
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2022-01-01
Marketing end: 2024-09-30
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 13 mg/5mL
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	73282-0125	73282-0125-1	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 · 11 matching rows.

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

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

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
73282-0125-1	2024-07-30	C162847	48780-1	1e7a6dab-1b5c-a2ce-e063-dadaa90aadf7	DrKids Children's Allergy Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73282-0125-1	Childrens Allergy Relief	5 mL in 1 VIAL, SINGLE-DOSE	SOLUTION	5		3
73282-0125-1	Childrens Allergy Relief	20 in 1 POUCH	SOLUTION	20		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73282-0125	CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE 12.5MG/5ML) SOLUTION [CALMCO LLC]	3	Legacy NDC, 2 package rows	20230722_e8450607-a68c-4729-e053-2995a90a2238.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	e8450607-a68c-4729-e053-2995a90a2238	3
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	e8450607-a68c-4729-e053-2995a90a2238	3
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	e8450607-a68c-4729-e053-2995a90a2238	3
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	e8450607-a68c-4729-e053-2995a90a2238	3
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	e8450607-a68c-4729-e053-2995a90a2238	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
73282-0125-1	73282012501	20 VIAL, SINGLE-DOSE in 1 POUCH (73282-0125-1) > 5 mL in 1 VIAL, SINGLE-DOSE	2022-01-01	2024-09-30	No	No	Current