Home NDC 36800-226-16 Topco Mucus Relief
Product NDC 36800-226
Requested package NDC 36800-226-16
11-digit product format 368000226
Labeler code 36800
Product ID 36800-226_201dbdbd-483f-46ee-8db2-e540d0b5cb9d
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler Topco Associates, LLC
Application ANDA209215
Marketing category ANDA
Marketing start 2021-06-01
Substance GUAIFENESIN
Active strength 600 mg/1
Pharmacologic classes Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209215-001 GUAIFENESIN GUAIFENESIN 600MG TABLET, EXTENDED RELEASE / ORAL 2017-09-06 A209215-002 GUAIFENESIN GUAIFENESIN 1.2GM TABLET, EXTENDED RELEASE / ORAL 2017-09-06
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A209215-001 GUAIFENESIN 600MG TABLET, EXTENDED RELEASE / ORAL 2017-09-06 a50c72e98297…2026-08-01 22:54:32 2026-06 A209215-002 GUAIFENESIN 1.2GM TABLET, EXTENDED RELEASE / ORAL 2017-09-06 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 15 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Topco Mucus Relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 600 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 636522 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 36800-226-16 Topco Mucus Relief 100 in 1 BOTTLE TABLET, EXTENDED RELEASE 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-226 TOPCO MUCUS RELIEF (GUAIFENESIN) TABLET, EXTENDED RELEASE [TOPCO ASSOCIATES, LLC] 2 Current NDC, Legacy NDC, 1 package rows 20221130_03c17c06-6919-4ef4-9d0a-4c039940c671.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 36800-226-16 36800022616 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (36800-226-16) 2021-06-01 0000-00-00 No No Current