robafen

Product NDC: 50090-4189
Requested package NDC: 50090-4189-0
11-digit product format: 500904189
Labeler code: 50090
Product ID: 50090-4189_396f2c58-458c-4d5e-a7a6-49a188253f9e
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin
Dosage form: SOLUTION
Route: ORAL
Labeler: A-S Medication Solutions
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2018-08-13
Marketing end: 0000-00-00
Substance: GUAIFENESIN
Active strength: 200 mg/10mL
NDC exclude flag: No
Listing certified through: 2022-12-31
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	50090-4189	50090-4189-0	I	Inactivated by FDA		2026-10-15

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, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-4189-0	2023-01-30	C162847	48780-1	f386c649-bf64-0266-e053-dadaa90a7c1a	Major Pharmaceuticals Robafen ™ Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-4189-0	robafen	473 mL in 1 BOTTLE	SOLUTION	473		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-4189-0	ML - Milliliter	50090-4189	8c744b94-d64b-4d28-a64f-0c51766e5ce7	1	2022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-4189	ROBAFEN (GUAIFENESIN) SOLUTION [A-S MEDICATION SOLUTIONS]	5	Legacy NDC, 1 package rows	20210417_65188fb6-1c0b-4e81-b0f7-af28d2b27b87.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	65188fb6-1c0b-4e81-b0f7-af28d2b27b87	5
213155	Robafen 200 MG in 10 mL Oral Solution	PSN	65188fb6-1c0b-4e81-b0f7-af28d2b27b87	5
213155	guaifenesin 20 MG/ML Oral Solution [Robafen]	SBD	65188fb6-1c0b-4e81-b0f7-af28d2b27b87	5
310604	guaifenesin 20 MG/ML Oral Solution	SCD	65188fb6-1c0b-4e81-b0f7-af28d2b27b87	5
310604	guaifenesin 100 MG per 5 ML Oral Solution	SY	65188fb6-1c0b-4e81-b0f7-af28d2b27b87	5
310604	guaifenesin 100 MG per 5 ML Oral Syrup	SY	65188fb6-1c0b-4e81-b0f7-af28d2b27b87	5
310604	guaifenesin 200 MG per 10 ML Oral Solution	SY	65188fb6-1c0b-4e81-b0f7-af28d2b27b87	5
310604	guaifenesin 300 MG per 15 ML Oral Solution	SY	65188fb6-1c0b-4e81-b0f7-af28d2b27b87	5
310604	guaifenesin 400 MG per 20 ML Oral Solution	SY	65188fb6-1c0b-4e81-b0f7-af28d2b27b87	5
213155	Robafen 100 MG per 5 mL Oral Solution	SY	65188fb6-1c0b-4e81-b0f7-af28d2b27b87	5
213155	Robafen 200 MG per 10 mL Oral Solution	SY	65188fb6-1c0b-4e81-b0f7-af28d2b27b87	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4189-0	50090418900	473 mL in 1 BOTTLE (50090-4189-0)	473 ml	2019-03-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Major Pharmaceuticals Robafen ™ Drug Facts	A-S Medication Solutions	2021-04-16	HUMAN OTC DRUG LABEL	5