FDA.reportPublic FDA data

daytime nitetime cold and flu

Product NDC
41250-601
11-digit product format
412500601
Labeler code
41250
Product ID
41250-601_ead1ea16-943d-4ebe-8c30-fd2294c6e7fe
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, dextromethorphan HBr, Doxylamine Succinate, Guaifenesin, Phenylephrine HCl
Dosage form
KIT
Labeler
Meijer Distribution Inc
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-07-23
Marketing end
2020-12-01
Active strength
0
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct41250-601DDiscontinued by firm2026-07-31
excluded productproduct41250-601IInactivated by FDA2026-07-31
excluded packagepackage41250-60141250-601-02DDiscontinued by firm2026-07-31
excluded packagepackage41250-60141250-601-12IInactivated 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41250-601-122020-01-31C16284748780-19d75b9d0-53da-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-601-12Meijer Maximum Strength Urinary Pain Relief1 in 1 CARTONTABLET11
41250-601-12Meijer Maximum Strength Urinary Pain Relief12 in 1 BLISTER PACKTABLET121

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DDAYTIME NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHDAYTIME NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC]1
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2DAYTIME NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC]1
GUAIFENESINACTIVE INGREDIENT495W7451VQDAYTIME NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJDAYTIME NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DDAYTIME NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSDAYTIME NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC]1
DOXYLAMINEACTIVE MOIETY95QB77JKPLDAYTIME NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC]1
GUAIFENESINACTIVE MOIETY495W7451VQDAYTIME NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVDAYTIME NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MDAYTIME NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDAYTIME NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UDAYTIME NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDAYTIME NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KDAYTIME NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SDAYTIME NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DAYTIME NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDAYTIME NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3ADAYTIME NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADAYTIME NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DAYTIME NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYDAYTIME NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUDAYTIME NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XDAYTIME NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRDAYTIME NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC]1
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWDAYTIME NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC]1
SORBITOLINACTIVE INGREDIENT506T60A25RDAYTIME NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4DAYTIME NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC]1
SUCROSEINACTIVE INGREDIENTC151H8M554DAYTIME NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC]1
WATERINACTIVE INGREDIENT059QF0KO0RDAYTIME NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEDAYTIME NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-601MEIJER MAXIMUM STRENGTH URINARY PAIN RELIEF (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [MEIJER DISTRIBUTION INC.]1Legacy NDC, 2 package rows20160115_d1a800b0-cd33-487a-baf9-bd116abf478d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094357phenazopyridine HCl 97.5 MG Oral TabletPSNd1a800b0-cd33-487a-baf9-bd116abf478d1
1094357phenazopyridine hydrochloride 97.5 MG Oral TabletSCDd1a800b0-cd33-487a-baf9-bd116abf478d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
41250-601-12412500601121 in 1 CARTONHistorical