FDA.reportPublic FDA data

Guaifenesin

Product NDC
50383-063
Requested package NDC
50383-063-17
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50383-06350383-063-17DDiscontinued 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

FDA-Initiated Inactive NDC Indexing#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50383-063-05Guaifenesin5 mL in 1 CUP, UNIT-DOSESOLUTION55
50383-063-05Guaifenesin10 in 1 TRAYSOLUTION105
50383-063-06Guaifenesin4 in 1 CASESOLUTION45
50383-063-07Guaifenesin10 in 1 CASESOLUTION105
50383-063-07Guaifenesin10 in 1 TRAYSOLUTION105
50383-063-10Guaifenesin10 mL in 1 CUP, UNIT-DOSESOLUTION105
50383-063-10Guaifenesin10 in 1 TRAYSOLUTION105
50383-063-11Guaifenesin4 in 1 CASESOLUTION45
50383-063-12Guaifenesin10 in 1 CASESOLUTION105
50383-063-12Guaifenesin10 in 1 TRAYSOLUTION105
50383-063-15Guaifenesin10 in 1 TRAYSOLUTION105
50383-063-15Guaifenesin15 mL in 1 CUP, UNIT-DOSESOLUTION155
50383-063-17Guaifenesin4 in 1 CASESOLUTION45
50383-063-18Guaifenesin10 in 1 CASESOLUTION105
50383-063-18Guaifenesin10 in 1 TRAYSOLUTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-063-05ML - Milliliter50383-06390f2681f-afb7-4e36-afb4-a505fa388a7d12013-03-03
50383-063-06ML - Milliliter50383-06317f28703-e107-4725-86df-a941a457143612013-04-01
50383-063-07ML - Milliliter50383-063fb73d3f2-e1d5-4211-be50-56b51942778412013-04-01
50383-063-10ML - Milliliter50383-063ac73897c-e6f2-4348-8bef-8f6b201e6c9412013-03-03
50383-063-11ML - Milliliter50383-0638d826061-57b2-48a1-80c2-219564aaf67512013-04-01
50383-063-12ML - Milliliter50383-06309d5fbbe-30aa-4c0a-af48-adc60f7f01ed12013-04-01
50383-063-15ML - Milliliter50383-063017a7ed6-c24b-421e-ba5f-5d3f0ad1514412013-03-03
50383-063-17ML - Milliliter50383-063f77887dd-e551-452d-9bca-23316d145c4412013-04-01
50383-063-18ML - Milliliter50383-063c10ed5b9-53c1-41f3-a2ef-2a35849dab0012013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GUAIFENESINACTIVE INGREDIENT495W7451VQGUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]2
GUAIFENESINACTIVE MOIETY495W7451VQGUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]2
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLGUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]2
HYPROMELLOSE 2910 (4000 MPA.S)INACTIVE INGREDIENTRN3152OP35GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]2
MENTHOLINACTIVE INGREDIENTL7T10EIP3AGUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]2
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RGUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-063GUAIFENESIN SOLUTION [AKORN]5Legacy NDC, 15 package rows20221116_5cb704a7-301c-494e-948f-872ee0d5a289.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN5cb704a7-301c-494e-948f-872ee0d5a2895
310604guaifenesin 20 MG/ML Oral SolutionSCD5cb704a7-301c-494e-948f-872ee0d5a2895
310604guaifenesin 100 MG per 5 ML Oral SolutionSY5cb704a7-301c-494e-948f-872ee0d5a2895
310604guaifenesin 100 MG per 5 ML Oral SyrupSY5cb704a7-301c-494e-948f-872ee0d5a2895
310604guaifenesin 200 MG per 10 ML Oral SolutionSY5cb704a7-301c-494e-948f-872ee0d5a2895
310604guaifenesin 300 MG per 15 ML Oral SolutionSY5cb704a7-301c-494e-948f-872ee0d5a2895
310604guaifenesin 400 MG per 20 ML Oral SolutionSY5cb704a7-301c-494e-948f-872ee0d5a2895
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSNc4a6dbbc-cbaf-43ce-922a-48289ae624c91
310604guaifenesin 20 MG/ML Oral SolutionSCDc4a6dbbc-cbaf-43ce-922a-48289ae624c91
310604guaifenesin 100 MG per 5 ML Oral SolutionSYc4a6dbbc-cbaf-43ce-922a-48289ae624c91
310604guaifenesin 100 MG per 5 ML Oral SyrupSYc4a6dbbc-cbaf-43ce-922a-48289ae624c91
310604guaifenesin 200 MG per 10 ML Oral SolutionSYc4a6dbbc-cbaf-43ce-922a-48289ae624c91
310604guaifenesin 300 MG per 15 ML Oral SolutionSYc4a6dbbc-cbaf-43ce-922a-48289ae624c91
310604guaifenesin 400 MG per 20 ML Oral SolutionSYc4a6dbbc-cbaf-43ce-922a-48289ae624c91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50383-063-17503830063174 TRAY in 1 CASE (50383-063-17) > 10 CUP, UNIT-DOSE in 1 TRAY (50383-063-15) > 15 mL in 1 CUP, UNIT-DOSE4 tray2012-03-070000-00-00NoNoCurrent