FDA.reportPublic FDA data

robafen

Product NDC
0904-6763
Requested package NDC
0904-6763-16
11-digit product format
009046763
Labeler code
0904
Product ID
0904-6763_2c946d4b-760f-49e7-a3ec-367b24fbeb22
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
Major Pharmaceuticals
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0904-67630904-6763-16DDiscontinued by firm2026-10-12

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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 conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6763-16ML - Milliliter0904-6763ffd1de6e-9420-4f95-aeae-ee1de667f2d912019-04-11
0904-6763-20ML - Milliliter0904-676388428996-a6a1-479f-9fbd-5d5597d6069712018-12-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN65188fb6-1c0b-4e81-b0f7-af28d2b27b875
213155Robafen 200 MG in 10 mL Oral SolutionPSN65188fb6-1c0b-4e81-b0f7-af28d2b27b875
213155guaifenesin 20 MG/ML Oral Solution [Robafen]SBD65188fb6-1c0b-4e81-b0f7-af28d2b27b875
310604guaifenesin 20 MG/ML Oral SolutionSCD65188fb6-1c0b-4e81-b0f7-af28d2b27b875
310604guaifenesin 100 MG per 5 ML Oral SolutionSY65188fb6-1c0b-4e81-b0f7-af28d2b27b875
310604guaifenesin 100 MG per 5 ML Oral SyrupSY65188fb6-1c0b-4e81-b0f7-af28d2b27b875
310604guaifenesin 200 MG per 10 ML Oral SolutionSY65188fb6-1c0b-4e81-b0f7-af28d2b27b875
310604guaifenesin 300 MG per 15 ML Oral SolutionSY65188fb6-1c0b-4e81-b0f7-af28d2b27b875
310604guaifenesin 400 MG per 20 ML Oral SolutionSY65188fb6-1c0b-4e81-b0f7-af28d2b27b875
213155Robafen 100 MG per 5 mL Oral SolutionSY65188fb6-1c0b-4e81-b0f7-af28d2b27b875
213155Robafen 200 MG per 10 mL Oral SolutionSY65188fb6-1c0b-4e81-b0f7-af28d2b27b875

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6763-1600904676316473 mL in 1 BOTTLE (0904-6763-16) 473 ml2018-12-102022-02-28NoNoCurrent