Home NDC 85828-723 Mucus Relief
Product NDC 85828-723
11-digit product format 858280723
Labeler code 85828
Product ID 85828-723_4cf63f34-143f-6575-e063-6294a90a0f80
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler Grocery Outlet, Inc.
Application ANDA217780
Marketing category ANDA
Marketing start 2026-03-13
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 2027-12-31
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 A217780-001 GUAIFENESIN GUAIFENESIN 600MG TABLET, EXTENDED RELEASE / ORAL 2023-08-21 A217780-002 GUAIFENESIN GUAIFENESIN 1.2GM TABLET, EXTENDED RELEASE / ORAL 2023-08-21
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 A217780-001 GUAIFENESIN 600MG TABLET, EXTENDED RELEASE / ORAL 2023-08-21 a50c72e98297…2026-08-01 22:54:32 2026-06 A217780-002 GUAIFENESIN 1.2GM TABLET, EXTENDED RELEASE / ORAL 2023-08-21 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 · 10 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Mucus Relief
Listing expiration 2027-12-31 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 85828-723-02 Mucus Relief 1 in 1 CARTON TABLET, EXTENDED RELEASE 1 2 85828-723-02 Mucus Relief 20 in 1 BLISTER PACK TABLET, EXTENDED RELEASE 20 2
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85828-723-02 85828072302 1 BLISTER PACK in 1 CARTON (85828-723-02) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 1 blister pack 2026-03-13 No No Current