Home NDC 85786-301 Dr Simi Mucus Relief Expectorant
Product NDC 85786-301
11-digit product format 857860301
Labeler code 85786
Product ID 85786-301_3c6d0e75-a686-6020-e063-6294a90a5c1b
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler Farmacias De Similares TX LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-08-15
Substance GUAIFENESIN
Active strength 1200 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 Dr Simi Mucus Relief Expectorant
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 1200 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 310621 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 85786-301-14 Dr Simi Mucus Relief Expectorant 14 in 1 BOTTLE TABLET, EXTENDED RELEASE 14 1
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 73 of 178 · 3,551 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 85786-301-14 85786030114 14 TABLET, EXTENDED RELEASE in 1 BOTTLE (85786-301-14) 2025-08-15 No No Current