Mucus Relief D Sinus Congestion

Product NDC: 63868-801
Requested package NDC: 63868-801-27
11-digit product format: 638680801
Labeler code: 63868
Product ID: 63868-801_6e90a4aa-aaf6-40d1-933c-f7c1575f3a8b
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin, Pseudoephedrine HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: CHAIN DRUG MARKETING ASSOCIATION INC
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2020-04-23
Marketing end: 0000-00-00
Substance: GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 400 mg/1; mg/1
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-Adrenergic Agonist [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	63868-801	63868-801-27	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 · 5 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…`

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
63868-801-27	EA - Each	63868-801	4971bb29-f785-414b-847a-7709f175a468	1	2022-09-12

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
6V9V2RYJ8N	PSEUDOEPHEDRINE HYDROCHLORIDE	345-78-8	PSEUDOEPHEDRINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63868-801-27	63868080127	3 BLISTER PACK in 1 CARTON (63868-801-27) > 9 TABLET, FILM COATED in 1 BLISTER PACK	3 blister pack	2020-04-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Quality Choice 44-547	CHAIN DRUG MARKETING ASSOCIATION INC \| LNK International, Inc.	2024-03-13	HUMAN OTC DRUG LABEL	7

Mucus Relief D Sinus Congestion

NDC auxiliary status#

Observed NDC auxiliary status history#

Reported adverse events (FAERS/openFDA)#

DailyMed Billing Units#

Related Records#

Related UNII Ingredients#

Packages#

Related DailyMed Labels#