Diphenhydramine Hydrochloride

Product NDC: 70000-0207
11-digit product format: 700000207
Labeler code: 70000
Product ID: 70000-0207_c4fcd8bc-0bb7-c0a3-e053-2995a90a8b49
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Cardinal Health
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2017-01-13
Marketing end: 0000-00-00
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 25 mg/1
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70000-0207		D	Discontinued by firm	2026-10-05
excluded package	package	70000-0207	70000-0207-1	D	Discontinued by firm	2026-10-05
excluded package	package	70000-0207	70000-0207-2	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 · 4 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	70000-0207-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70000-0207-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70000-0207-2	`f5e01cc5f278…`	`a2eaf40c39c3…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70000-0207-1	EA - Each	70000-0207	73ef5e69-b13a-4adb-a8f0-5eaf94405f43	1	2017-11-06
70000-0207-2	EA - Each	70000-0207	891bca17-6cfd-411a-b7d2-dfad8f83f3f1	1	2017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70000-0207	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [LEADER/ CARDINAL HEALTH 110, INC.]	7	Legacy NDC	20250212_2e3b4e65-d090-4e44-9c03-60c3064b74fa.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70000-0207-1	70000020701	2 BLISTER PACK in 1 CARTON (70000-0207-1) > 12 CAPSULE in 1 BLISTER PACK	2 blister pack	2017-01-31	0000-00-00	No	No	Current
70000-0207-2	70000020702	100 CAPSULE in 1 BOTTLE (70000-0207-2)	100 capsule	2017-03-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
0835 - Cardinal	LEADER/ Cardinal Health 110, Inc.	2025-08-13	HUMAN OTC DRUG LABEL	8
0835 - Cardinal	REMEDYREPACK INC.	2022-04-12	HUMAN OTC DRUG LABEL	1