GUAIFENESIN 400MG CAPLETS

Product NDC: 77333-360
11-digit product format: 773330360
Labeler code: 77333
Product ID: 77333-360_48032e44-d1b5-ea4d-e063-6394a90aba26
Type: HUMAN OTC DRUG
Nonproprietary name: GUAIFENESIN
Dosage form: TABLET
Route: ORAL
Labeler: Gendose Pharmaceuticals, LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-09-02
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: 2027-12-31
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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product	77333-360		I	Inactivated by FDA		excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	77333-360	77333-360-10	I	Inactivated by FDA		excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

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 400MG CAPLETS
Listing expiration: 2027-12-31

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
e7b82ec7-ef23-50c1-e053-2a95a90a662f	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-05-02	GENDOSE - GUAIFENESIN 400 mg CAPLETS (77333-360)
2024-05-02	GENDOSE - GUAIFENESIN 400 mg CAPLETS (77333-360)
2024-01-30	GENDOSE - GUAIFENESIN 400 mg CAPLETS (77333-360)
2024-01-30	GENDOSE - GUAIFENESIN 400 mg CAPLETS (77333-360)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
77333-360-10	GUAIFENESIN 400MG CAPLETS	100 in 1 BOX	TABLET	100		7
77333-360-25	GUAIFENESIN 400MG CAPLETS	1 in 1 BLISTER PACK	TABLET	1		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
77333-360-10	EA - Each	77333-360	59e4bbd3-6be1-4beb-b0d0-7887c8855797	1	2022-10-06
77333-360-25	EA - Each	77333-360	3f337a09-e952-4310-a7aa-c0fc1effdaf0	1	2022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
77333-360	GUAIFENESIN 400MG CAPLETS (GUAIFENESIN) TABLET [GENDOSE PHARMACEUTICALS, LLC]	5	Current NDC, Legacy NDC, 2 package rows	20240504_e7b82ec7-ef23-50c1-e053-2a95a90a662f.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 36 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Panadol Cold and Flu Night	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	3417993d-8e3c-23d6-e063-6394a90a7d50	2026-04-29	Warnings	Exact identifier application number: M012
Halls Sugar Free Mountain Menthol	MENTHOL	Mondelez Global LLC	509f233e-ff01-8927-e063-6394a90a9929	2026-04-29	Warnings	Exact identifier application number: M012
Broncomiel Adults	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Pharmadel LLC	509c61d3-ae16-be5c-e063-6294a90a68da	2026-04-29	Warnings	Exact identifier application number: M012
Mucus Relief DM Max Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN	TOP CARE (Topco Associates LLC)	aa1eb90c-e565-455f-8978-6f2f9e00a814	2026-04-29	Warnings	Exact identifier application number: M012
Tussin Cough and Chest Congestion DM adult	DEXTROMETHORPHAN HBR, GUAIFENESIN	Harris Teeter, LLC	e1280355-da81-489f-9bd2-ffea9a68010c	2026-04-29	Warnings	Exact identifier application number: M012
Mucus Relief Childrens	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	TOPCO ASSOCIATES LLC	7b095ec5-9951-4491-9b68-7ac0a7f10053	2026-04-29	Warnings	Exact identifier application number: M012
Mucus Relief Severe Congestion and Cough Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	TOP CARE (Topco Associates LLC)	98dd0ba6-0109-46b2-92df-11a030984240	2026-04-28	Warnings	Exact identifier application number: M012
Pain, Headache and Congestion	ACETAMINOPHEN, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	41a77cbb-6a4d-46a4-ab27-c7affa2cc682	2026-04-28	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Severe Fast Dissolve	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	dd7da15a-4e0b-405f-e053-2995a90a06d2	2026-04-28	Warnings	Exact identifier application number: M012
CAREONE CHILDRENS COLD COUGH	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Retail Business Services, LLC	382f7d51-ceb8-4bdf-9bd5-440b50c65cd3	2026-04-28	Warnings	Exact identifier application number: M012
Cold and Flu Daytime Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	L.N.K. International, Inc.	1a520b4f-6a4b-4e37-94c5-9387f2e4c34a	2026-04-27	Warnings	Exact identifier application number: M012
Childrens Multi-Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Kroger	49a7cd2a-8c0e-2196-e063-6294a90a134a	2026-04-27	Warnings	Exact identifier application number: M012
Guaifenesin,Dextromethorphan Hbr	GUAIFENESIN,DEXTROMETHORPHAN HBR	Softgel Healthcare Pvt Ltd	3e5d978f-cc70-60a5-e063-6394a90a67d3	2026-04-27	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE	Softgel Healthcare Pvt Ltd	36ced59c-12dc-441f-e063-6294a90a3239	2026-04-27	Warnings	Exact identifier application number: M012
Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg	ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL	Softgel Healthcare Private Limited	30ab39f3-27cc-5728-e063-6394a90a9cbe	2026-04-27	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate	ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE	Softgel Healthcare Private Limited	353f71f7-81e0-08c2-e063-6294a90acb49	2026-04-27	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan HBr ,Guaifenesin	ACETAMINOPHEN, DEXTROMETHORPHAN HBR ,GUAIFENESIN	Softgel Healthcare Pvt Ltd	353ef34f-760d-ae92-e063-6294a90a5b4a	2026-04-27	Warnings	Exact identifier application number: M012
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	SOFTGEL HEALTHCARE PRIVATE LIMITED	0203d919-dc1f-cca0-e063-6394a90aa1aa	2026-04-27	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Severe Fast Dissolve	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	507214ad-1e06-fe21-e063-6294a90a59cd	2026-04-27	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Congestion Severe Day Night Fast Dissolve	ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	50738a43-7299-270c-e063-6294a90af2cc	2026-04-27	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	e7b82ec7-ef23-50c1-e053-2a95a90a662f	7
359601	guaifenesin 400 MG Oral Tablet	SCD	e7b82ec7-ef23-50c1-e053-2a95a90a662f	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
77333-360-10	77333036010	100 BLISTER PACK in 1 BOX (77333-360-10) / 1 TABLET in 1 BLISTER PACK (77333-360-25)	100 blister pack	2022-09-02	0000-00-00	No	No	Current
77333-360-25	77333036025	1 in 1 BLISTER PACK						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GENDOSE - GUAIFENESIN 400 mg CAPLETS (77333-360)	Gendose Pharmaceuticals, LLC \| ELYSIUM PHARMACEUTICALS LIMITED	2026-01-10	HUMAN OTC DRUG LABEL	7