Home NDC 0363-0028 Guaifenesin
Product NDC 0363-0028
11-digit product format 003630028
Labeler code 0363
Product ID 0363-0028_4c76abec-f8fe-498d-a322-76b6f45a57f8
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler WALGREEN CO.
Application ANDA210453
Marketing category ANDA
Marketing start 2020-05-08
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 A210453-001 GUAIFENESIN GUAIFENESIN 600MG TABLET, EXTENDED RELEASE / ORAL 2019-10-21 A210453-002 GUAIFENESIN GUAIFENESIN 1.2GM TABLET, EXTENDED RELEASE / ORAL 2019-10-21
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 A210453-001 GUAIFENESIN 600MG TABLET, EXTENDED RELEASE / ORAL 2019-10-21 a50c72e98297…2026-08-01 22:54:32 2026-06 A210453-002 GUAIFENESIN 1.2GM TABLET, EXTENDED RELEASE / ORAL 2019-10-21 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 · 16 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Guaifenesin
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0363-0028-96 Guaifenesin 1 in 1 CARTON TABLET, EXTENDED RELEASE 1 7 0363-0028-96 Guaifenesin 20 in 1 BLISTER PACK TABLET, EXTENDED RELEASE 20 7 0363-0028-97 Guaifenesin 20 in 1 BLISTER PACK TABLET, EXTENDED RELEASE 20 7 0363-0028-97 Guaifenesin 2 in 1 CARTON TABLET, EXTENDED RELEASE 2 7 0363-0028-98 Guaifenesin 20 in 1 BLISTER PACK TABLET, EXTENDED RELEASE 20 7 0363-0028-98 Guaifenesin 5 in 1 CARTON TABLET, EXTENDED RELEASE 5 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-0028 GUAIFENESIN TABLET, EXTENDED RELEASE [WALGREEN CO.] 6 Current NDC, Legacy NDC, 6 package rows 20241206_51a35002-77ba-47e5-93ab-3f28242d16b6.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 0363-0028-96 00363002896 1 BLISTER PACK in 1 CARTON (0363-0028-96) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 1 blister pack 2020-05-08 0000-00-00 No No Current 0363-0028-97 00363002897 2 BLISTER PACK in 1 CARTON (0363-0028-97) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 2 blister pack 2020-05-08 0000-00-00 No No Current 0363-0028-98 00363002898 5 BLISTER PACK in 1 CARTON (0363-0028-98) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 5 blister pack 2020-05-08 0000-00-00 No No Current