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 103 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
McKesson Sugar Free Cough Suppressant Oral Anesthetic	MENTHOL LOZENGE	McKesson Medical-Surgical	e0dfa6ca-b311-25cb-e053-2a95a90a12cc	2025-09-09	Warnings	Exact identifier application number: M012
Medique at Home Decorel Forte	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Unifirst First Aid Corporation	e648f017-9e30-df6c-e053-2995a90adcd0	2025-09-09	Warnings	Exact identifier application number: M012
Medi-First Honey Lemon Cough Drops	MENTHOL 8.6 MG	Unifirst First Aid Corporation	826e1b87-e5a9-8637-e053-2991aa0aded1	2025-09-09	Warnings	Exact identifier application number: M012
Unishield Cherry Cough	MENTHOL	Unishield	b8297bc1-44b2-3de0-e053-2995a90ad01b	2025-09-09	Warnings	Exact identifier application number: M012
McKesson Cough Supressant	MENTHOL	McKesson Medical-Surgical	db5e0490-2ed8-2d53-e053-2a95a90a98f5	2025-09-09	Warnings	Exact identifier application number: M012
Duratuss AC	CODEINE PHOSPHATE, DEXBROMPHENIRAMINE MALEATE	Poly Pharmaceuticals, Inc.	3e5ed178-d5d9-b8d4-e063-6394a90a91db	2025-09-09	Warnings	Exact identifier application number: M012
Rompe Pecho CF	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Efficient Laboratories Inc	96c4dee1-6e66-4442-a7e3-56e874414c17	2025-09-09	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Lil Drug Store Products	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	Lil' Drug Store Products, Inc	57c458ed-7987-453b-ab24-bbfa6580f920	2025-09-09	Warnings	Exact identifier application number: M012
equate MAXIMUM STRENGTH NIGHTTIME SEVERE Cold and Flu SOFTGELS	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	WALMART INC.	38637189-d1ee-9405-e063-6394a90ae8b8	2025-09-09	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Walgreens	fd52d8d8-7cd1-4e92-86da-354a1d5213c2	2025-09-08	Warnings	Exact identifier application number: M012
Green Guard Advanced Sinus Relief	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE	Unifirst First Aid Corporation	e8e5fb21-a7fd-44d1-b9c4-83e949699ca6	2025-09-08	Warnings	Exact identifier application number: M012
Medi-First Sinus Decongestant	PHENYLEPHRINE HYDROCHLORIDE	Unifirst First Aid Corporation	9654f5cd-74d7-44a2-9674-666d1e94ffa7	2025-09-08	Warnings	Exact identifier application number: M012
Otis Clapp Mygrex	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE	Unifirst First Aid Corporation	f196f2c5-a100-42b1-bd01-0327b223838e	2025-09-08	Warnings	Exact identifier application number: M012
Medique Diphen	DIPHENHYDRAMINE HYDROCHLORIDE	Unifirst First Aid Corporation	b61ee2e0-2543-447d-9fc4-23363d46ce04	2025-09-08	Warnings	Exact identifier application number: M012
Green Guard Allergy 2 Relief	PHENYLEPHRINE HYDROCHLORIDE	Unifirst First Aid Corporation	16fddca9-a66b-41e6-9423-eaf091d3971e	2025-09-08	Warnings	Exact identifier application number: M012
Medique Medi-Phenyl	PHENYLEPHRINE HYDROCHLORIDE	Unifirst First Aid Corporation	d7d62ac1-1333-4366-884b-26537766ce38	2025-09-08	Warnings	Exact identifier application number: M012
Unishield Sinus Decongestant	PHENYLEPHRINE HCL	Unishield	b8f68d9d-2d38-414a-e053-2a95a90a15ec	2025-09-08	Warnings	Exact identifier application number: M012
McKesson Sinus Pain and Pressure Relief	ACETAMINOPHEN, PHENYLEPHRINE HCL	McKesson Medical-Surgical	e0cbb213-4f4f-4045-e053-2a95a90a2a18	2025-09-08	Warnings	Exact identifier application number: M012
Medique Medicidin D	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE	Unifirst First Aid Corporation	1f172d58-4050-424b-9743-130d8e618fe8	2025-09-08	Warnings	Exact identifier application number: M012
Medique Cold Cough Product	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL ,	Unifirst First Aid Corporation	e8059137-efba-398c-e053-2a95a90a21f2	2025-09-08	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