FDA.reportPublic FDA data

Cough Mucus Relief DM

Product NDC
70692-101
11-digit product format
706920101
Labeler code
70692
Product ID
70692-101_b193b6ae-555b-7d3e-e053-2a95a90a6814
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr and Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
Strive Pharmaceuticals Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2018-02-15
Marketing end
0000-00-00
Substance
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
400 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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70692-101IInactivated by FDA2026-07-31
excluded packagepackage70692-10170692-101-24IInactivated by FDA2026-07-31
excluded packagepackage70692-10170692-101-41IInactivated by FDA2026-07-31

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxymethazoline HCLOXYMETHAZOLINE HCLPreferred Pharmaceuticals Inc.cebf4a9c-b5c6-4ad8-ab7e-9bd3a80678c42026-07-29WarningsExact identifier
Pi Yuan ChinNAPHAZOLINE HYDROCHLORIDEInternational Nature Nutraceuticalse7aedab9-da4c-4494-a896-1e6ed2a956fe2025-12-27WarningsExact identifier
Childrens Multi-symptom Cold DaytimeDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWal-Mart Stores, Inc.1768677d-96ec-f9f7-e063-6394a90a4ef42025-11-21WarningsExact identifier
robafen dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINPreferred Pharmaceuticals Inc.5b2fd5ce-56ab-491a-81b9-44e35a5d23162025-09-17WarningsExact identifier
TussinGUAIFENESINStrategic Sourcing Services188f3c82-b4bc-42a5-8068-c2fa0c2ac3442025-01-08WarningsExact identifier
Tussin CFDEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCLStrategic Sourcing Servicese416982f-6cbb-4f48-a215-16bea8393dad2025-01-07WarningsExact identifier
QCH Adult Tussin DM 542DEXTROMETHORPHAN HBR, GUAIFENESINChain Drug Marketing Association Inc.17caffa4-a264-7f3e-e063-6394a90ac4192024-05-08WarningsExact identifier
QCH Adult Tussin DM Sugar free 545DEXTROMETHORPHAN HBR, GUAIFENESINChain Drug Marketing Association Inc.17cb91f0-32ec-9e0f-e063-6394a90a05092024-05-08WarningsExact identifier
QCH Adult Tussin 541GUAIFENESINChain Drug Marketing Association Inc.b487f4af-ad0c-4f18-9a6b-7fd386b3f46c2024-05-02WarningsExact identifier
QCH Maximum Strength Mucus Relief DM 628DEXTROMETHORPHAN HBR, GUAIFENESINChain Drug Marketing Association Inc.a2795bf5-34c6-4de6-b9e5-53a23d18e3572024-04-26WarningsExact identifier
Childrens Mucus and Cough ReliefDEXTROMETHORPHAN HBR, GUAIFENESINFamily Dollar Services, Inc.07ad76cc-2a6c-4a88-a5e9-5e8f6d1319e32024-04-17WarningsExact identifier
Quality Choice Dye Free Cherry Childrens Allergy ReliefDIPHENHYDRAMINE HCLChain Drug Marketing Association Inc.302ca7b5-f65c-4187-bbd6-f482be6e63c12024-03-18WarningsExact identifier
MUCUS RELIEF DMDEXTROMETHORPHAN HBR/GUAIFENESINKROGER COMPANY813baf42-edb0-33a9-e053-2a91aa0a85992019-05-21WarningsExact identifier
MUCUS RELIEFGUAIFENESINKROGER COMPANY813b1db2-a177-77c6-e053-2a91aa0ac73b2019-05-15WarningsExact identifier
Discount Drug Mart Value Vapor SteamCAMPHOR (SYNTHETIC)Drug Mart87230c40-ea77-0f3a-e053-2991aa0ae7842019-04-22WarningsExact identifier
Best Choice Vapor SteamCAMPHOR (SYNTHETIC)Valu merchandiser86bb3a80-c675-d478-e053-2a91aa0a8c272019-04-17WarningsExact identifier
Assured Vaporizing Chest RubCAMPHOR AND EUCALYPTUS OIL AND MENTHOLGreenbrier International, Inc.c7cdbf2f-4841-4a7a-9056-6a741abc31332019-01-19WarningsExact identifier
Assured Vaporizing Chest RubCAMPHOR AND EUCALYPTUS OIL AND MENTHOLGreenbrier International, Inc.b8f0c61e-83b0-4835-b950-2c5dcce5cf172019-01-19WarningsExact identifier
Pressure Pain Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEChain Drug Marketing Association1e54ecb3-c3c3-477a-8725-23f24e77a44b2018-12-31WarningsExact identifier
Allergy TimeCHLORPHENIRAMINE MALEATETime Cap Labs Inc588c424a-8dd6-417e-8f76-2ce0cc2b0c122018-12-17WarningsExact 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#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70692-101-242022-01-28C16284748780-1d6a99b39-9691-a426-e053-dadaa90af4c2Dextromethorphan HBr 20mg and Guaifenesin 400mg
70692-101-412022-01-28C16284748780-1d6a99b39-9691-a426-e053-dadaa90af4c2Dextromethorphan HBr 20mg and Guaifenesin 400mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70692-101-24Cough Mucus Relief DM24 in 1 BOTTLETABLET244
70692-101-41Cough Mucus Relief DM4 in 1 PACKAGETABLET44

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70692-101COUGH MUCUS RELIEF DM (DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET [STRIVE PHARMACEUTICALS INC.]4Legacy NDC, 2 package rows20201014_6878aed8-df32-19f1-e053-2991aa0a614e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1147685dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral TabletPSN6878aed8-df32-19f1-e053-2991aa0a614e4
1147685dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral TabletSCD6878aed8-df32-19f1-e053-2991aa0a614e4
1147685guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral TabletSY6878aed8-df32-19f1-e053-2991aa0a614e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70692-101-247069201012424 TABLET in 1 BOTTLE (70692-101-24) 24 tablet2018-02-150000-00-00NoNoCurrent
70692-101-41706920101414 TABLET in 1 PACKAGE (70692-101-41) 4 tablet2018-12-200000-00-00NoNoCurrent