Mucus Relief Sinus

Product NDC: 68788-7872
Requested package NDC: 68788-7872-3
11-digit product format: 687887872
Labeler code: 68788
Product ID: 68788-7872_40560df0-8607-4b84-8989-399b97eda96b
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin and Phenylephrine HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2021-02-18
Marketing end: 0000-00-00
Substance: GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 400 mg/1; 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68788-7872	68788-7872-3	I	Inactivated by FDA		2026-10-12

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 · 15 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…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68788-7872-2	2023-01-30	C162847	48780-1	f386c649-f37d-0266-e053-dadaa90a7c1a	Major 44-542
68788-7872-3	2023-01-30	C162847	48780-1	f386c649-f37d-0266-e053-dadaa90a7c1a	Major 44-542
68788-7872-6	2023-01-30	C162847	48780-1	f386c649-f37d-0266-e053-dadaa90a7c1a	Major 44-542

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68788-7872-2	Mucus Relief Sinus	20 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	20	2
68788-7872-3	Mucus Relief Sinus	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	2
68788-7872-6	Mucus Relief Sinus	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-7872	MUCUS RELIEF SINUS (GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]	2	Legacy NDC, 3 package rows	20210226_a2cf1318-d2c1-4335-97d0-98e752e5649d.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1304111	guaiFENesin 400 MG / phenylephrine HCl 10 MG Oral Tablet	PSN	a2cf1318-d2c1-4335-97d0-98e752e5649d	2
1304111	guaifenesin 400 MG / phenylephrine hydrochloride 10 MG Oral Tablet	SCD	a2cf1318-d2c1-4335-97d0-98e752e5649d	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7872-3	68788787203	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-7872-3)	2021-02-18	0000-00-00	No	No	Current