Home NDC 70692-108 Acetaminophen 500mg, Dextromethorphan HBr 10mg, Guaifenesin 200mg, Phenylephrine HCl 5mg
Product NDC 70692-108
11-digit product format 706920108
Labeler code 70692
Product ID 70692-108_b43d2d83-1d7c-6187-e053-2a95a90a7bc2
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen 500mg, Dextromethorphan HBr 10mg, Guaifenesin 200mg, Phenylephrine HCl 5mg
Dosage form TABLET
Route ORAL
Labeler Strive Pharmaceuticals Inc
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2018-12-20
Marketing end 0000-00-00
Substance GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN
Active strength 200 mg/1; mg/1; mg/1; mg/1
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record NDC auxiliary status# Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date excluded product product 70692-108 I Inactivated by FDA 2026-07-31 excluded package package 70692-108 70692-108-41 I Inactivated by FDA 2026-07-31
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Oxymethazoline HCL OXYMETHAZOLINE HCL Preferred Pharmaceuticals Inc. cebf4a9c-b5c6-4ad8-ab7e-9bd3a80678c4 2026-07-29 Warnings Exact identifier Pi Yuan Chin NAPHAZOLINE HYDROCHLORIDE International Nature Nutraceuticals e7aedab9-da4c-4494-a896-1e6ed2a956fe 2025-12-27 Warnings Exact identifier Childrens Multi-symptom Cold Daytime DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL Wal-Mart Stores, Inc. 1768677d-96ec-f9f7-e063-6394a90a4ef4 2025-11-21 Warnings Exact identifier robafen dm DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN Preferred Pharmaceuticals Inc. 5b2fd5ce-56ab-491a-81b9-44e35a5d2316 2025-09-17 Warnings Exact identifier Tussin GUAIFENESIN Strategic Sourcing Services 188f3c82-b4bc-42a5-8068-c2fa0c2ac344 2025-01-08 Warnings Exact identifier Tussin CF DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL Strategic Sourcing Services e416982f-6cbb-4f48-a215-16bea8393dad 2025-01-07 Warnings Exact identifier QCH Adult Tussin DM 542 DEXTROMETHORPHAN HBR, GUAIFENESIN Chain Drug Marketing Association Inc. 17caffa4-a264-7f3e-e063-6394a90ac419 2024-05-08 Warnings Exact identifier QCH Adult Tussin DM Sugar free 545 DEXTROMETHORPHAN HBR, GUAIFENESIN Chain Drug Marketing Association Inc. 17cb91f0-32ec-9e0f-e063-6394a90a0509 2024-05-08 Warnings Exact identifier QCH Adult Tussin 541 GUAIFENESIN Chain Drug Marketing Association Inc. b487f4af-ad0c-4f18-9a6b-7fd386b3f46c 2024-05-02 Warnings Exact identifier QCH Maximum Strength Mucus Relief DM 628 DEXTROMETHORPHAN HBR, GUAIFENESIN Chain Drug Marketing Association Inc. a2795bf5-34c6-4de6-b9e5-53a23d18e357 2024-04-26 Warnings Exact identifier Childrens Mucus and Cough Relief DEXTROMETHORPHAN HBR, GUAIFENESIN Family Dollar Services, Inc. 07ad76cc-2a6c-4a88-a5e9-5e8f6d1319e3 2024-04-17 Warnings Exact identifier Quality Choice Dye Free Cherry Childrens Allergy Relief DIPHENHYDRAMINE HCL Chain Drug Marketing Association Inc. 302ca7b5-f65c-4187-bbd6-f482be6e63c1 2024-03-18 Warnings Exact identifier MUCUS RELIEF DM DEXTROMETHORPHAN HBR/GUAIFENESIN KROGER COMPANY 813baf42-edb0-33a9-e053-2a91aa0a8599 2019-05-21 Warnings Exact identifier MUCUS RELIEF GUAIFENESIN KROGER COMPANY 813b1db2-a177-77c6-e053-2a91aa0ac73b 2019-05-15 Warnings Exact identifier Discount Drug Mart Value Vapor Steam CAMPHOR (SYNTHETIC) Drug Mart 87230c40-ea77-0f3a-e053-2991aa0ae784 2019-04-22 Warnings Exact identifier Best Choice Vapor Steam CAMPHOR (SYNTHETIC) Valu merchandiser 86bb3a80-c675-d478-e053-2a91aa0a8c27 2019-04-17 Warnings Exact identifier Assured Vaporizing Chest Rub CAMPHOR AND EUCALYPTUS OIL AND MENTHOL Greenbrier International, Inc. c7cdbf2f-4841-4a7a-9056-6a741abc3133 2019-01-19 Warnings Exact identifier Assured Vaporizing Chest Rub CAMPHOR AND EUCALYPTUS OIL AND MENTHOL Greenbrier International, Inc. b8f0c61e-83b0-4835-b950-2c5dcce5cf17 2019-01-19 Warnings Exact identifier Pressure Pain Mucus PE ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE Chain Drug Marketing Association 1e54ecb3-c3c3-477a-8725-23f24e77a44b 2018-12-31 Warnings Exact identifier Allergy Time CHLORPHENIRAMINE MALEATE Time Cap Labs Inc 588c424a-8dd6-417e-8f76-2ce0cc2b0c12 2018-12-17 Warnings Exact identifier
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland When using this prduct do not use more than directed do not use more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. temporary discomfort such as burning, stinging, sneexing, or an increased nasal discharge may occur use of this container by more than one person may spread infection
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 70692-108-41 Acetaminophen 500mg, Dextromethorphan HBr 10mg, Guaifenesin 200mg, Phenylephrine HCl 5mg 4 in 1 PACKAGE TABLET 4 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70692-108 ACETAMINOPHEN 500MG, DEXTROMETHORPHAN HBR 10MG, GUAIFENESIN 200MG, PHENYLEPHRINE HCL 5MG TABLET [STRIVE PHARMACEUTICALS INC] 2 Legacy NDC, 1 package rows 20201117_9239bf18-0e2b-20d5-e053-2a95a90addc8.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 70692-108-41 70692010841 4 TABLET in 1 PACKAGE (70692-108-41) 4 tablet 2018-12-20 0000-00-00 No No Current