allergy relief Diphenhydramine HCI 25 mg Antihistamine

Product NDC: 70677-0162
Requested package NDC: 70677-0162-1
11-digit product format: 706770162
Labeler code: 70677
Product ID: 70677-0162_e20e49d9-a158-3e87-e053-2995a90a925c
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl
Dosage form: BAR, CHEWABLE
Route: ORAL
Labeler: Strategic Sourcing Services LLC
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2022-06-22
Marketing end: 0000-00-00
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70677-0162	70677-0162-1	D	Discontinued by firm		2026-10-05

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

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70677-0162-1	EA - Each	70677-0162	4b73baf8-830b-460f-bc34-81c82939e88b	1	2023-02-06

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70677-0162	ALLERGY RELIEF DIPHENHYDRAMINE HCI 25 MG ANTIHISTAMINE (DIPHENHYDRAMINE HCL) BAR, CHEWABLE [STRATEGIC SOURCING SERVICES LLC]	2	Legacy NDC	20241122_e215b97f-22eb-4cef-9e2d-b8a0df660bfc.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70677-0162-1	70677016201	1 BOTTLE, PLASTIC in 1 CARTON (70677-0162-1) > 10 BAR, CHEWABLE in 1 BOTTLE, PLASTIC	2022-06-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
allergy relief Diphenhydramine HCl 25 mg Antihistamine Drug Facts	Strategic Sourcing Services LLC \| USpharma Ltd	2024-11-20	HUMAN OTC DRUG LABEL	2