GUAIFENESIN

Product NDC: 16103-379
11-digit product format: 161030379
Labeler code: 16103
Product ID: 16103-379_3038393b-2c7b-4f5d-8b5d-d6054f663336
Type: HUMAN OTC DRUG
Nonproprietary name: GUAIFENESIN
Dosage form: TABLET
Route: ORAL
Labeler: Pharbest Pharmaceuticals, Inc.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-05-01
Substance: GUAIFENESIN
Active strength: 400 mg/1
Pharmacologic classes: Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 34 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	16103-379-04	I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	16103-379-04	I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	16103-379-04	I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	16103-379-04	I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	16103-379-04	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	16103-379-04	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	16103-379-04	I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	16103-379-04	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	16103-379-04	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	16103-379-04	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	16103-379-04	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	16103-379-04	I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	16103-379-04	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	16103-379-04	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	16103-379-04	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`263afe128892…`	`91768de4ddbe…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished package	package	16103-379-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`5b2001dcd8f5…`	`54b53d4dc9e4…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished package	package	16103-379-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`5b2001dcd8f5…`	`54b53d4dc9e4…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: GUAIFENESIN
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GUAIFENESIN	400 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
495W7451VQ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
359601	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0bf70fb4-d3c8-476d-b864-4eadc697a7d8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
16103-379-04	2025-12-25	C162847	48780-1	f386c64a-18e4-0266-e053-dadaa90a7c1a	Drug Facts
16103-379-04	2023-01-30	C162847	48780-1	f386c64a-18e4-0266-e053-dadaa90a7c1a	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16103-379-04	GUAIFENESIN	1 in 1 CARTON	TABLET	1		2
16103-379-04	GUAIFENESIN	30 in 1 BOTTLE, PLASTIC	TABLET	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16103-379	GUAIFENESIN TABLET [PHARBEST PHARMACEUTICALS, INC.]	1	Current NDC, Legacy NDC, 2 package rows	20210401_0bf70fb4-d3c8-476d-b864-4eadc697a7d8.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 3 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dollar General	NASAL PHENYLEPHRINE HYDROCHLORIDE	DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)	e8fd3f0e-a023-4423-8906-17ae02bc083b	2026-09-03	Warnings	Exact identifier application number: M012
Mucus Relief Congestion and Cough Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI	TARGET Corporation	1bf9a59e-cc37-4780-ba75-7138c546eb19	2026-09-02	Warnings	Exact identifier application number: M012
Childrens Multi Symptom Fever and Cold	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	THE KROGER CO.	3daf7620-eb57-43d5-ba88-938b7221e346	2026-09-02	Warnings	Exact identifier application number: M012
PHENAGIL	PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE	Gil Pharmaceutical Corp	69fd13a1-2b76-8574-e053-2a91aa0a27e7	2026-09-02	Warnings	Exact identifier application number: M012
PHENAGIL	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL	Gil Pharmaceutical Corp.	a6880389-0dc1-43a7-a73b-77f77bafe51e	2026-09-02	Warnings	Exact identifier application number: M012
PHENAGIL	PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE	Gil Pharmaceutical Corp	fa8510d8-d50a-4743-ba87-a12e9ab43125	2026-09-02	Warnings	Exact identifier application number: M012
PHENAGIL	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL	Gil Pharmaceutical Corp	dfcf1231-8271-458d-b375-e328d6fd4e9b	2026-09-02	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Multi Symptom Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Shield Pharmaceuticals Corp	decafa3a-3734-4161-bab0-121945881846	2026-09-02	Warnings	Exact identifier application number: M012
Kroger Maximum Strength Severe Congestion and Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN, AND PHENYLEPHRINE HCL	KROGER COMPANY	1ff037ea-1a3b-430a-be31-2e240cc3b6f3	2026-09-02	Warnings	Exact identifier application number: M012
KROGER Mucus Relief DM Maximum Strength	DEXTROMETHORPHAN HBR AND GUAIFENESIN	KROGER COMPANY	79d24014-1af7-4d62-bcb8-5bea76a7d6ee	2026-09-02	Warnings	Exact identifier application number: M012
Kroger No Drip	ALLERGY SINUS	KROGER COMPANY	4788bafb-8866-4a0a-b217-226513799c24	2026-09-02	Warnings	Exact identifier application number: M012
Maximum Strength Cold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	KROGER COMPANY	e1d27123-358f-4b0c-8e3b-33474750a0e6	2026-09-02	Warnings	Exact identifier application number: M012
Maximum Strength Nighttime Cold and Flu	ACETAMINOPHEN , DIPHENHYDRAMINE HCL,PHENYLEPHRINE HCL	THE KROGER CO	058b2021-8a61-40b0-8a2e-a784d2b847fb	2026-09-02	Warnings	Exact identifier application number: M012
KROGER Dye Free Childrens Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	KROGER COMPANY	2bea22e9-34b6-4961-94bb-5600dd90e891	2026-09-02	Warnings	Exact identifier application number: M012
KROGER No Drip Nasal Mist Severe Congestion	OXYMETAZOLINE HYDROCHLORIDE	KROGER COMPANY	7256e048-ad69-4322-844d-872f05e6fc8a	2026-09-02	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Relief	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCL	The Kroger Co.	494e69ef-dc9f-4e14-b856-5eaf0f541a03	2026-09-02	Warnings	Exact identifier application number: M012
MAX Tussin Cough and Chest Congestion DM Sugar Free	DEXTROMETHORPHAN HBR, GUAIFENESIN	Akron Pharma Inc.	5c4c8115-cec9-4f2c-9ea9-328535e97b07	2026-09-01	Warnings	Exact identifier application number: M012
MAX ALLERGY KIDS	DIPHENHYDRAMINE HCL	Akron Pharma Inc.	96c4ade8-67b1-41e5-8624-fb49090208af	2026-09-01	Warnings	Exact identifier application number: M012
MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH SUGAR FREE	HEXYLRESORCINOL AND MENTHOL	Reckitt Benckiser LLC	4a938e15-a996-8538-e063-6294a90ad4ee	2026-09-01	Warnings	Exact identifier application number: M012
Allergy Relief	CHLORPHENIRAMINE MALEATE	WALMART INC.	5e6623c3-6210-4c50-94d6-5554f36876d1	2026-08-31	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
359601	guaiFENesin 400 MG Oral Tablet	PSN	0bf70fb4-d3c8-476d-b864-4eadc697a7d8	2
359601	guaifenesin 400 MG Oral Tablet	SCD	0bf70fb4-d3c8-476d-b864-4eadc697a7d8	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16103-379-04	16103037904	1 BOTTLE, PLASTIC in 1 CARTON (16103-379-04) / 30 TABLET in 1 BOTTLE, PLASTIC	2018-05-01	0000-00-00	No	No	Current