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 60 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	DIPHENHYDRAMINE HCL	DOLGENCORP, LLC	bab078bb-f6b0-4394-84de-92b2c582b5da	2026-01-12	Warnings	Exact identifier application number: M012
Nasal Decongestant PE Non-Drowsy Maximum Strength	PHENYLEPHRINE HCL	CHAIN DRUG MARKETING ASSOCIATION INC	bf7246c1-90fe-4de8-8bb2-e5ff7e8ca63d	2026-01-12	Warnings	Exact identifier application number: M012
CVS Health Medicated Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	CVS Pharmacy	022c3083-c611-47d0-aa93-d6c7612e7a47	2026-01-11	Warnings	Exact identifier application number: M012
CVS Health Medicated Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	CVS Pharmacy	bf73d15a-9d68-42fa-bfee-d25748215f97	2026-01-11	Warnings	Exact identifier application number: M012
GUAIFENESIN 400MG CAPLETS	GUAIFENESIN	Gendose Pharmaceuticals, LLC	e7b82ec7-ef23-50c1-e053-2a95a90a662f	2026-01-10	Warnings	Exact identifier application number: M012 ndc (product): 77333-360
Daytime Cold and Flu	DAYTIME COLD AND FLU	Allegiant Health	69ed2da0-16b2-49eb-91b4-cc5cf328c817	2026-01-09	Warnings	Exact identifier application number: M012
HyVee Cough Drops Original Herb	MENTHOL	HY-VEE, INC	47f81e54-0ce4-439d-e063-6294a90a2abe	2026-01-09	Warnings	Exact identifier application number: M012
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	A-S Medication Solutions	a5809774-ed52-4f54-b48e-888631e0223d	2026-01-09	Warnings	Exact identifier application number: M012
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	A-S Medication Solutions	5767f546-a751-4583-a8b7-971175c27ef0	2026-01-09	Warnings	Exact identifier application number: M012
Thompson Cough and Cold Multi-Symptom Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE, GUAIFENESIN, ,	Thompson	e77725b1-15da-35bd-e053-2a95a90ad6ba	2026-01-08	Warnings	Exact identifier application number: M012
Mucosan Childrens Multi-Symptom Grape	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Menper Distributors, Inc.	266c8cce-cdf9-557d-e063-6394a90a9bc3	2026-01-08	Warnings	Exact identifier application number: M012
Mucosan Multi-Symptom Honey	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Menper Distributors, Inc.	2669c620-ab70-abaa-e063-6394a90a58e7	2026-01-08	Warnings	Exact identifier application number: M012
Mucosan Multi-Symptom Cherry	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Menper Distributors, Inc.	26b8c06d-4a72-3979-e063-6394a90a96d7	2026-01-08	Warnings	Exact identifier application number: M012
Mucosan Max with Acetaminophen	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE	Menper Distributors, Inc.	26a4861b-5d8e-9ec6-e063-6394a90af577	2026-01-08	Warnings	Exact identifier application number: M012
Mucosan Severe Multi-Symptom	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Menper Distributors, Inc.	26a69342-f65f-cb46-e063-6394a90ade10	2026-01-08	Warnings	Exact identifier application number: M012
HyVee Cough Drops Original Herb	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	e4e15c13-f583-4484-a5f0-f04c39c7b7c9	2026-01-08	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz Non Drowsy	ASPRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	a355d987-77ce-9e32-e053-2995a90a6431	2026-01-08	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Sinus, Congestion and Pain Power Max Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	e07931fc-f753-1aeb-e053-2a95a90ada3f	2026-01-08	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night	ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	fc60af2f-83cb-99ea-e053-6394a90a0b3b	2026-01-08	Warnings	Exact identifier application number: M012
Alka Seltzer Plus Maximum Strength Sinus, Allergy And Cough Power Max Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	e17eb929-209d-a2d1-e053-2a95a90a4cf3	2026-01-08	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	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