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 50 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	LEADER/ Cardinal Health 110, Inc.	e33cbd1d-1848-145a-e053-2995a90aeb50	2026-02-20	Warnings	Exact identifier application number: M012
Head Congestion and Flu Severe Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Rite Aid Corporation	416080a9-e817-485b-a4ae-6c9d0152c165	2026-02-20	Warnings	Exact identifier application number: M012
Walmart Dye Free Chidrens Allergy Chews	DIPHENHYDRAMINE HCL	WALMART STORES INC	18436026-b0e4-4481-a647-d735a27d0b00	2026-02-19	Warnings	Exact identifier application number: M012
Vaporizing	CAMPHOR	Meijer, Inc.	7afc98d7-f64f-42d5-9022-28ad6b01db8a	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M012
CHILDRENS COLD AND COUGH	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Kroger Company	8196b482-070e-4d7d-8943-129141f926ee	2026-02-19	Warnings	Exact identifier application number: M012
Walmart Dye Free Chidrens Allergy Chews Bubblegum	DIPHENHYDRAMINE HCL	WALMART STORES INC	9f83d2f0-9718-4f2b-bc7f-e29ba2917412	2026-02-19	Warnings	Exact identifier application number: M012
tussin dm max	DEXTROMETHORPHAN HBR, GUAIFENESIN	Kroger Company	be9aaf66-6c59-4042-88e2-acd920dcf992	2026-02-19	Warnings	Exact identifier application number: M012
Allergy Relief Dye-Free	DIPHENHYDRAMINE HCL	CVS Pharmacy	08459cf4-feb3-4283-88e1-d61e030c57f9	2026-02-19	Warnings	Exact identifier application number: M012
allergy relief	CHLORPHENIRAMINE MALEATE	Rite Aid Corporation	b0d70488-ea1d-4c1d-bd07-53dfb0e4d03c	2026-02-18	Warnings	Exact identifier application number: M012
Walgreens Wild Cherry Pectin Throat Drops	PECTIN	Walgreens	424fda2d-c1e5-0ed9-e063-6394a90a06ea	2026-02-18	Warnings	Exact identifier application number: M012
cough suppressant and topical analgesic	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Target Corporation	df21d9d6-36a9-49cf-a29c-c4a573899bd5	2026-02-18	Warnings, Adverse reactions	Exact identifier application number: M012
Allergy Relief	CHLORPHENIRAMINE MALEATE	Amerisource Bergen	eeda80ff-212d-428e-a0c6-782f271357b4	2026-02-18	Warnings	Exact identifier application number: M012
good sense night time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	L. Perrigo Company	e47dffdf-5778-4804-8ce2-54c5a72bba3a	2026-02-18	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	United Natural Foods, Inc. dba UNFI	b139e7d6-bf4d-45b9-b7cf-d34e5352095c	2026-02-17	Warnings, Adverse reactions	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Strategic Sourcing Services LLC	bd54bf7a-2304-4c3f-9cd2-bafea217466e	2026-02-17	Warnings, Adverse reactions	Exact identifier application number: M012
Creomulsion For Children	DEXTROMETHORPHAN HYDROBROMIDE	Socius Care, LLC	39d0e96c-1cc3-4961-e054-00144ff88e88	2026-02-17	Warnings	Exact identifier application number: M012
Creomulsion Cough Medicine Adult Formula	DEXTROMETHORPHAN HYDROBROMIDE	Socius Care, LLC	39d07486-99b7-5c06-e054-00144ff8d46c	2026-02-17	Warnings	Exact identifier application number: M012
Cold and Flu Severe, Day, Night	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR. GUAIFENESIN, PHENYLEPHRINE HCL	L.N.K. International, Inc.	6e6bae79-1231-4b74-81c1-f0c914ed4af3	2026-02-17	Warnings	Exact identifier application number: M012
COUGH AND CHEST CONGESTION	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	dfe69c12-b5fe-46d1-a3bf-ef3729c2e786	2026-02-17	Warnings	Exact identifier application number: M012
NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	3fb49f64-2d77-44db-8186-5904837eedbe	2026-02-17	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