Home NDC 63868-148 Maximum Strength Mucus Relief
Product NDC 63868-148
11-digit product format 638680148
Labeler code 63868
Product ID 63868-148_2435d335-106c-2322-e063-6394a90a1b26
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler CHAIN DRUG MARKETING ASSOCIATION INC
Application ANDA213420
Marketing category ANDA
Marketing start 2021-09-17
Marketing end 2027-02-28
Substance GUAIFENESIN
Active strength 1200 mg/1
Pharmacologic classes Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag No
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 A213420-001 GUAIFENESIN GUAIFENESIN 600MG TABLET, EXTENDED RELEASE / ORAL 2020-05-08 A213420-002 GUAIFENESIN GUAIFENESIN 1.2GM TABLET, EXTENDED RELEASE / ORAL 2020-05-08
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 A213420-001 GUAIFENESIN 600MG TABLET, EXTENDED RELEASE / ORAL 2020-05-08 a50c72e98297…2026-08-01 22:54:32 2026-06 A213420-002 GUAIFENESIN 1.2GM TABLET, EXTENDED RELEASE / ORAL 2020-05-08 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 3 · 58 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Maximum Strength Mucus Relief 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 63868-148-14 Maximum Strength Mucus Relief 2 in 1 CARTON TABLET, EXTENDED RELEASE 2 3 63868-148-14 Maximum Strength Mucus Relief 7 in 1 BLISTER PACK TABLET, EXTENDED RELEASE 7 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63868-148 MAXIMUM STRENGTH MUCUS RELIEF (GUAIFENESIN) TABLET, EXTENDED RELEASE [CHAIN DRUG MARKETING ASSOCIATION INC] 3 Current NDC, Legacy NDC, 2 package rows 20241013_c20f64e3-485b-4ea7-b73d-56e5c898ed2e.zip
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 63868-148-14 63868014814 2 BLISTER PACK in 1 CARTON (63868-148-14) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 2 blister pack 2021-09-17 2027-02-28 No No Current