Guaifenesin

Product NDC: 50383-063
Requested package NDC: 50383-063-18
11-digit product format: 503830063
Labeler code: 50383
Product ID: 50383-063_2651ad0c-0f3f-44e2-8273-d480d6f50ecc
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin
Dosage form: SOLUTION
Route: ORAL
Labeler: Akorn
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2012-03-07
Marketing end: 0000-00-00
Substance: GUAIFENESIN
Active strength: 100 mg/5mL
Pharmacologic classes: Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50383-063	50383-063-18	I	Inactivated by FDA		2026-10-12

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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, Related label table
NDC	Related label
50383-063-06	Drug Facts
50383-063-07	Drug Facts
50383-063-11	Drug Facts
50383-063-12	Drug Facts
50383-063-17	Drug Facts
50383-063-18	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50383-063-05	Guaifenesin	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5	5
50383-063-05	Guaifenesin	10 in 1 TRAY	SOLUTION	10	5
50383-063-06	Guaifenesin	4 in 1 CASE	SOLUTION	4	5
50383-063-07	Guaifenesin	10 in 1 CASE	SOLUTION	10	5
50383-063-07	Guaifenesin	10 in 1 TRAY	SOLUTION	10	5
50383-063-10	Guaifenesin	10 mL in 1 CUP, UNIT-DOSE	SOLUTION	10	5
50383-063-10	Guaifenesin	10 in 1 TRAY	SOLUTION	10	5
50383-063-11	Guaifenesin	4 in 1 CASE	SOLUTION	4	5
50383-063-12	Guaifenesin	10 in 1 CASE	SOLUTION	10	5
50383-063-12	Guaifenesin	10 in 1 TRAY	SOLUTION	10	5
50383-063-15	Guaifenesin	10 in 1 TRAY	SOLUTION	10	5
50383-063-15	Guaifenesin	15 mL in 1 CUP, UNIT-DOSE	SOLUTION	15	5
50383-063-17	Guaifenesin	4 in 1 CASE	SOLUTION	4	5
50383-063-18	Guaifenesin	10 in 1 CASE	SOLUTION	10	5
50383-063-18	Guaifenesin	10 in 1 TRAY	SOLUTION	10	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50383-063-05	ML - Milliliter	50383-063	90f2681f-afb7-4e36-afb4-a505fa388a7d	1	2013-03-03
50383-063-06	ML - Milliliter	50383-063	17f28703-e107-4725-86df-a941a4571436	1	2013-04-01
50383-063-07	ML - Milliliter	50383-063	fb73d3f2-e1d5-4211-be50-56b519427784	1	2013-04-01
50383-063-10	ML - Milliliter	50383-063	ac73897c-e6f2-4348-8bef-8f6b201e6c94	1	2013-03-03
50383-063-11	ML - Milliliter	50383-063	8d826061-57b2-48a1-80c2-219564aaf675	1	2013-04-01
50383-063-12	ML - Milliliter	50383-063	09d5fbbe-30aa-4c0a-af48-adc60f7f01ed	1	2013-04-01
50383-063-15	ML - Milliliter	50383-063	017a7ed6-c24b-421e-ba5f-5d3f0ad15144	1	2013-03-03
50383-063-17	ML - Milliliter	50383-063	f77887dd-e551-452d-9bca-23316d145c44	1	2013-04-01
50383-063-18	ML - Milliliter	50383-063	c10ed5b9-53c1-41f3-a2ef-2a35849dab00	1	2013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]	2
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]	2
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]	2
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]	2
HYPROMELLOSE 2910 (4000 MPA.S)	INACTIVE INGREDIENT	RN3152OP35	GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]	2
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]	2
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50383-063	GUAIFENESIN SOLUTION [AKORN]	5	Legacy NDC, 15 package rows	20221116_5cb704a7-301c-494e-948f-872ee0d5a289.zip

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
310604	guaiFENesin 100 MG in 5 mL Oral Solution	PSN	5cb704a7-301c-494e-948f-872ee0d5a289	5
310604	guaifenesin 20 MG/ML Oral Solution	SCD	5cb704a7-301c-494e-948f-872ee0d5a289	5
310604	guaifenesin 100 MG per 5 ML Oral Solution	SY	5cb704a7-301c-494e-948f-872ee0d5a289	5
310604	guaifenesin 100 MG per 5 ML Oral Syrup	SY	5cb704a7-301c-494e-948f-872ee0d5a289	5
310604	guaifenesin 200 MG per 10 ML Oral Solution	SY	5cb704a7-301c-494e-948f-872ee0d5a289	5
310604	guaifenesin 300 MG per 15 ML Oral Solution	SY	5cb704a7-301c-494e-948f-872ee0d5a289	5
310604	guaifenesin 400 MG per 20 ML Oral Solution	SY	5cb704a7-301c-494e-948f-872ee0d5a289	5
310604	guaiFENesin 100 MG in 5 mL Oral Solution	PSN	c4a6dbbc-cbaf-43ce-922a-48289ae624c9	1
310604	guaifenesin 20 MG/ML Oral Solution	SCD	c4a6dbbc-cbaf-43ce-922a-48289ae624c9	1
310604	guaifenesin 100 MG per 5 ML Oral Solution	SY	c4a6dbbc-cbaf-43ce-922a-48289ae624c9	1
310604	guaifenesin 100 MG per 5 ML Oral Syrup	SY	c4a6dbbc-cbaf-43ce-922a-48289ae624c9	1
310604	guaifenesin 200 MG per 10 ML Oral Solution	SY	c4a6dbbc-cbaf-43ce-922a-48289ae624c9	1
310604	guaifenesin 300 MG per 15 ML Oral Solution	SY	c4a6dbbc-cbaf-43ce-922a-48289ae624c9	1
310604	guaifenesin 400 MG per 20 ML Oral Solution	SY	c4a6dbbc-cbaf-43ce-922a-48289ae624c9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50383-063-18	50383006318	10 TRAY in 1 CASE (50383-063-18) > 10 CUP, UNIT-DOSE in 1 TRAY > 15 mL in 1 CUP, UNIT-DOSE	10 tray	2012-03-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Akorn \| Akorn Operating Compnay LLC	2022-11-15	HUMAN OTC DRUG LABEL	5
Drug Facts	A-S Medication Solutions	2021-03-02	HUMAN OTC DRUG LABEL	1