Home NDC 55319-551 Mucus Relief
Product NDC 55319-551
11-digit product format 553190551
Labeler code 55319
Product ID 55319-551_eb96a48c-7f7c-4ddd-bdc7-f71b3d9c1321
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler Family Dollar (FAMILY WELLNESS)
Application ANDA207342
Marketing category ANDA
Marketing start 2023-07-01
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 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 A207342-001 GUAIFENESIN GUAIFENESIN 600MG TABLET, EXTENDED RELEASE / ORAL 2018-07-11 A207342-002 GUAIFENESIN GUAIFENESIN 1.2GM TABLET, EXTENDED RELEASE / ORAL 2018-07-11
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 A207342-001 GUAIFENESIN 600MG TABLET, EXTENDED RELEASE / ORAL 2018-07-11 a50c72e98297…2026-08-01 22:54:32 2026-06 A207342-002 GUAIFENESIN 1.2GM TABLET, EXTENDED RELEASE / ORAL 2018-07-11 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 2 · 30 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mucus Relief Extended Release Maximum Strength GUAIFENESIN CVS Pharmacy 34314503-b253-4b44-96ff-a42fe2bb161f 2026-07-22 Warnings Exact identifier application applno (ANDA): 207342 application number: ANDA207342 Mucus Relief ER GUAIFENESIN Cardinal Health 107, LLC f7abc2ff-21bc-48b5-9989-c5ac84f5c9cd 2026-07-21 Warnings Exact identifier application applno (ANDA): 207342 application number: ANDA207342 Mucus Relief GUAIFENESIN Rugby Laboratories ee413595-2687-4c38-84ce-18aac933d8e3 2026-07-15 Warnings Exact identifier application applno (ANDA): 207342 application number: ANDA207342 Mucus Relief Extended Release GUAIFENESIN TARGET Corporation e521e8e1-8227-451a-8858-01c26f6e0657 2026-07-06 Warnings Exact identifier application applno (ANDA): 207342 application number: ANDA207342 Mucus Relief GUAIFENESIN Harris Teeter, LLC f7f2e64c-0fb9-413d-80ed-4d7cc2a07e0c 2026-05-01 Warnings Exact identifier application applno (ANDA): 207342 application number: ANDA207342 Mucus Relief Maximum Strength GUAIFENESIN Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 3ee82152-7c6f-4d93-909d-e1c50eee27e5 2026-04-20 Warnings Exact identifier application applno (ANDA): 207342 application number: ANDA207342 Mucus Relief GUAIFENESIN Best Choice (Valu Merchandisers Company) 9bac4bbb-a20c-48c5-891b-63f14a664d04 2026-04-15 Warnings Exact identifier application applno (ANDA): 207342 application number: ANDA207342 Mucus Relief Extended Release Maximum Strength GUAIFENESIN CARDINAL HEALTH 110, LLC. DBA LEADER 70000 54a59e95-f95a-4bcd-ac9d-8d4ace85277f 2026-02-10 Warnings Exact identifier application applno (ANDA): 207342 application number: ANDA207342 Mucus Relief GUAIFENESIN Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 32f58b4a-3e1b-424f-8296-a9bf9a7d7025 2025-11-11 Warnings Exact identifier application applno (ANDA): 207342 application number: ANDA207342 Mucus Relief GUAIFENESIN Family Dollar (FAMILY WELLNESS) 1e1a9335-58ac-4722-9188-c847e62e7215 2025-11-05 Warnings Exact identifier application applno (ANDA): 207342 application number: ANDA207342 ndc (product): 55319-551 Mucus Relief GUAIFENESIN Family Dollar (FAMILY WELLNESS) ddc18f31-acb2-4305-929a-f4746efd4224 2025-10-24 Warnings Exact identifier application applno (ANDA): 207342 application number: ANDA207342 Mucus Relief Extended Release Maximum Strength GUAIFENESIN Walgreens e4b27b9b-5f3b-4314-9717-54d73cf6b74e 2025-08-28 Warnings Exact identifier application applno (ANDA): 207342 application number: ANDA207342 Mucus Relief GUAIFENESIN Rite Aid Corporation 73fb2194-a582-4d3c-bc82-c5f110efcd81 2025-08-20 Warnings Exact identifier application applno (ANDA): 207342 application number: ANDA207342 Mucus Relief Extended Release GUAIFENESIN Rugby Laboratories, Inc. 8bc6f08e-a941-4fa8-8dd6-a699abf2337d 2025-04-21 Warnings Exact identifier application applno (ANDA): 207342 application number: ANDA207342 Mucus Relief GUAIFENESIN H E B efebda97-5234-451c-a854-91a32303a6b7 2025-03-17 Warnings Exact identifier application applno (ANDA): 207342 application number: ANDA207342 Mucus Relief ER GUAIFENESIN Major Pharmaceuticals e5a242bf-3008-4c92-a930-e76f733be5cf 2025-03-07 Warnings Exact identifier application applno (ANDA): 207342 application number: ANDA207342 Mucus Relief GUAIFENESIN P & L Development, LLC a2d14780-4a69-496e-86fe-7f2443cb0f20 2025-02-12 Warnings Exact identifier application applno (ANDA): 207342 application number: ANDA207342 Mucus Relief Extended Release GUAIFENESIN Redpharm Drug Inc. f4c1e725-bcae-2255-e053-2995a90ad335 2025-01-23 Warnings Exact identifier application applno (ANDA): 207342 application number: ANDA207342 Mucus Relief GUAIFENESIN P & L Development, LLC 3c01a88f-35c8-4e43-9997-ebee7943820f 2024-11-14 Warnings Exact identifier application applno (ANDA): 207342 application number: ANDA207342 Guaifenesin GUAIFENESIN Amneal Pharmaceuticals LLC ad67e6fd-a68f-44db-9718-84a2cef86e09 2024-10-07 Warnings Exact identifier application applno (ANDA): 207342 application number: ANDA207342
Additional Listing Data#
Finished product Yes
Brand name base Mucus Relief
Listing expiration 2026-12-31 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 55319-551-07 Mucus Relief 7 in 1 CARTON TABLET, EXTENDED RELEASE 7 4 55319-551-07 Mucus Relief 1 in 1 BLISTER PACK TABLET, EXTENDED RELEASE 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55319-551 MUCUS RELIEF (GUAIFENESIN) TABLET, EXTENDED RELEASE [FAMILY DOLLAR (FAMILY WELLNESS)] 3 Current NDC, 2 package rows 20230802_1e1a9335-58ac-4722-9188-c847e62e7215.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 55319-551-07 55319055107 7 BLISTER PACK in 1 CARTON (55319-551-07) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 7 blister pack 2023-07-01 No No Current