allergy

Product NDC: 70677-0004
Requested package NDC: 70677-0004-1
11-digit product format: 706770004
Labeler code: 70677
Product ID: 70677-0004_0d90060b-4166-4240-a84e-d18ed54d8b37
Type: HUMAN OTC DRUG
Nonproprietary name: Chlorpheniramine maleate
Dosage form: TABLET
Route: ORAL
Labeler: Strategic Sourcing Services, LLC (Sunmark)
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 1992-12-19
Marketing end: 0000-00-00
Substance: CHLORPHENIRAMINE MALEATE
Active strength: 4 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	70677-0004	70677-0004-1	D	Discontinued by firm		2026-10-16

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70677-0004	70677-0004-1	D	Discontinued by firm		excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70677-0004	70677-0004-1	D	Discontinued by firm		excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`

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
70677-0004-1	EA - Each	70677-0004	a5f39af8-d0ff-4666-87f2-b0f97dd4e126	1	2017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70677-0004	ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [STRATEGIC SOURCING SERVICES LLC]	15	Legacy NDC	20250411_02aa77fe-c15d-4132-b853-80fd65d6af13.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V1Q0O9OJ9Z	CHLORPHENIRAMINE MALEATE	113-92-8	CHLORPHENIRAMINE MALEATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70677-0004-1	70677000401	1 BOTTLE in 1 CARTON (70677-0004-1) > 100 TABLET in 1 BOTTLE	1 bottle	1992-12-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sunmark 44-194-Delisted	Strategic Sourcing Services LLC \| LNK International, Inc.	2025-04-10	HUMAN OTC DRUG LABEL	15