Pharbinex

Product NDC: 73057-379
11-digit product format: 730570379
Labeler code: 73057
Product ID: 73057-379_2c27dcbe-d14a-a6dd-e063-6294a90a9395
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin 400mg
Dosage form: TABLET
Route: ORAL
Labeler: Ulai Health LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-06-26
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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	73057-379-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	73057-379-04	`0efc9e666f02…`	`f202fb6c5f17…`

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: Pharbinex
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
4eafa81a-aeee-4c97-85d6-594902b10919	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
73057-379-04	2022-01-31	C162847	48780-1	d6a99b39-5065-a426-e053-dadaa90af4c2	Drug Facts
73057-379-04	2022-01-28	C162847	48780-1	d6a99b39-5065-a426-e053-dadaa90af4c2	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73057-379-04	Pharbinex	30 in 1 BOTTLE, PLASTIC	TABLET	30		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73057-379	PHARBINEX (GUAIFENESIN 400MG) TABLET [ULAI HEALTH LLC]	5	Current NDC, Legacy NDC, 1 package rows	20250122_4eafa81a-aeee-4c97-85d6-594902b10919.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 100 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rompe Pecho CF	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Dextrum Laboratories, Inc	401a97af-36ae-4e54-e063-6294a90ab3ee	2025-10-01	Warnings	Exact identifier application number: M012
NyQuil Severe plus Vicks VapoCool Cold and Flu	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE	The Procter & Gamble Manufacturing Company	724d0889-5ba5-3125-e053-2a91aa0a92c1	2025-10-01	Warnings	Exact identifier application number: M012
DayQuil Severe plus Vicks VapoCool Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	The Procter & Gamble Manufacturing Company	724f2833-34bd-6a9e-e053-2991aa0a073d	2025-10-01	Warnings	Exact identifier application number: M012
Phenylephrine Hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	InvaTech Pharma Solutions LLC	b8d360fa-0d80-f6a8-e053-2a95a90a8bd4	2025-10-01		Exact identifier application number: M012
LEADER TUSSIN CF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Cardinal Health 110, LLC. dba Leader	f4ffe87b-0a62-44ac-b84a-08cf77cda7f5	2025-10-01	Warnings	Exact identifier application number: M012
Nasal Spray, 1oz, 24/7 Life by 7-Eleven	OXYMETAZOLINE HCL NASAL SOLUTION 0.05%	Lil' Drug Store Products, Inc.	3e781417-9ffc-f2c9-e063-6294a90a7205	2025-09-30	Warnings	Exact identifier application number: M012
Original Extra Strong All Natural Fishermans Friend Menthol Cough Suppressant	MENTHOL	Lofthouse of Fleetwood, Ltd.	d8f4a65b-cf2c-4424-b27f-e3e0ffadd9cf	2025-09-30	Warnings	Exact identifier application number: M012
Giltuss Honey Cough and Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	Dextrum Laboratories, Inc	3ff240ba-90b2-4c17-e063-6394a90ac56f	2025-09-29	Warnings	Exact identifier application number: M012
Dometuss	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Dextrum Laboratories, Inc	3fcace53-a81f-e774-e063-6294a90a32fa	2025-09-27	Warnings	Exact identifier application number: M012
nitetime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Meijer Distribution Inc	f6a3680a-3ac6-4fd4-be52-ce29064c4aa1	2025-09-26	Warnings	Exact identifier application number: M012
No Drip Severe Nasal Mist	OXYMETAZOLINE SPRAY	CVS Health	9d9f6c03-0ae1-4f3b-80cd-b23b7c4bdae5	2025-09-26	Warnings	Exact identifier application number: M012
Giltuss Allergy Plus	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Dextrum Laboratories Inc.	3fa0b3be-2124-ed1d-e063-6294a90aaf48	2025-09-25	Warnings	Exact identifier application number: M012
MGC Health Cough Drops Honey Herb	MENTHOL	Medical Group Care LLC	3fa17255-514f-db47-e063-6294a90ae454	2025-09-25	Warnings	Exact identifier application number: M012
MGC Health Cough Drops Honey Herb	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	3fa17272-fd7f-9ab4-e063-6394a90a585f	2025-09-25	Warnings	Exact identifier application number: M012
MGC Health Throat Soothing Drops Creamy Strawberry	PECTIN	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	3fa2e438-2ff3-a2df-e063-6394a90ac7b5	2025-09-25	Warnings	Exact identifier application number: M012
QUALITY CHOICE ADULT TUSSIN EXPECTORANT	GUAIFENESIN	QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)	63dad603-fe2f-42a6-a626-5c8048a42c10	2025-09-25	Warnings	Exact identifier application number: M012
Giltuss Childrens Allergy Plus	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Dextrum Laboratories Inc.	3fa5220f-38bb-9ef6-e063-6294a90aeff8	2025-09-25	Warnings	Exact identifier application number: M012
Acetaminophen 325 mg, Dextromethorphan Hydrobromide 10 mg, Phenlyephrine Hydrochloride 5 mg softgel (DAY-TIME)	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Health Pharma USA LLC	a03befb4-d86d-43e4-8097-eda5c8bb25be	2025-09-24	Warnings	Exact identifier application number: M012
Childrens Giltuss EX Expectorant	GUAIFENESIN	Dextrum Laboratories Inc.	3f8d7d47-f14c-888c-e063-6394a90a5cdd	2025-09-24	Warnings	Exact identifier application number: M012
Childrens Giltuss Honey Cough and Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	Dextrum Laboratories, Inc	3f909bc2-eb84-a19d-e063-6294a90ae04e	2025-09-24	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	4eafa81a-aeee-4c97-85d6-594902b10919	5
359601	guaifenesin 400 MG Oral Tablet	SCD	4eafa81a-aeee-4c97-85d6-594902b10919	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
73057-379-04	73057037904	30 TABLET in 1 BOTTLE, PLASTIC (73057-379-04)	30 tablet	2019-06-26	0000-00-00	No	No	Current