Home NDC 0904-5154 Guaifenesin
Product NDC 0904-5154
11-digit product format 009045154
Labeler code 0904
Product ID 0904-5154_9a9743de-1619-4d95-868f-d125b1d409e4
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin
Dosage form TABLET
Route ORAL
Labeler Major Pharmaceuticals
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2009-10-05
Substance GUAIFENESIN
Active strength 200 mg/1
Pharmacologic classes Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 Guaifenesin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 200 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 197741 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0904-5154-60 Guaifenesin 100 in 1 BOTTLE, PLASTIC TABLET 100 26
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ GUAIFENESIN TABLET [MAJOR PHARMACEUTICALS] 13 GUAIFENESIN ACTIVE MOIETY 495W7451VQ GUAIFENESIN TABLET [MAJOR PHARMACEUTICALS] 13 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U GUAIFENESIN TABLET [MAJOR PHARMACEUTICALS] 13 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 GUAIFENESIN TABLET [MAJOR PHARMACEUTICALS] 13 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D GUAIFENESIN TABLET [MAJOR PHARMACEUTICALS] 13 POVIDONES INACTIVE INGREDIENT FZ989GH94E GUAIFENESIN TABLET [MAJOR PHARMACEUTICALS] 13 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP GUAIFENESIN TABLET [MAJOR PHARMACEUTICALS] 13 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ GUAIFENESIN TABLET [PHYSICIANS TOTAL CARE, INC.] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ GUAIFENESIN TABLET [CONTRACT PHARMACY SERVICES-PA] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ GUAIFENESIN TABLET [PHYSICIANS TOTAL CARE, INC.] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ GUAIFENESIN TABLET [CONTRACT PHARMACY SERVICES-PA] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U GUAIFENESIN TABLET [PHYSICIANS TOTAL CARE, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U GUAIFENESIN TABLET [CONTRACT PHARMACY SERVICES-PA] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA GUAIFENESIN TABLET [CONTRACT PHARMACY SERVICES-PA] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 GUAIFENESIN TABLET [PHYSICIANS TOTAL CARE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 GUAIFENESIN TABLET [CONTRACT PHARMACY SERVICES-PA] 1 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D GUAIFENESIN TABLET [CONTRACT PHARMACY SERVICES-PA] 1 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D GUAIFENESIN TABLET [PHYSICIANS TOTAL CARE, INC.] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E GUAIFENESIN TABLET [CONTRACT PHARMACY SERVICES-PA] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E GUAIFENESIN TABLET [PHYSICIANS TOTAL CARE, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 GUAIFENESIN TABLET [CONTRACT PHARMACY SERVICES-PA] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 GUAIFENESIN TABLET [CONTRACT PHARMACY SERVICES-PA] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP GUAIFENESIN TABLET [CONTRACT PHARMACY SERVICES-PA] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP GUAIFENESIN TABLET [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-5154 GUAIFENESIN TABLET [MAJOR PHARMACEUTICALS] 25 Current NDC, Legacy NDC, 1 package rows 20250512_aa662428-e61f-4e22-af4d-8cf63df68c99.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 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0904-5154-60 00904515460 100 TABLET in 1 BOTTLE, PLASTIC (0904-5154-60) 100 tablet 2009-10-05 0000-00-00 No No Current