FDA.reportPublic FDA data

NDC 53413-011 - Cough Tabs For Dogs and Cats

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
53413-011
Package NDCs from labels
53413-011-25, 53413-011-10
Manufacturer
Creative Science
Effective date
2026-01-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cough Tabs For Dogs and Cats - Creative ScienceCreative Science2026-01-06OTC ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53413-011-10Cough Tabs For Dogs and Cats1000 in 1 BOTTLETABLET10008
53413-011-25Cough Tabs For Dogs and Cats250 in 1 BOTTLETABLET2508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53413-011COUGH TABS FOR DOGS AND CATS (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) TABLET [CREATIVE SCIENCE]72 package rows20250115_44c16497-3077-4d7b-85ad-d1df01de4130.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCOUGH TABS FOR DOGS AND CATS (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) TABLET [CREATIVE SCIENCE LLC]2
GUAIFENESINACTIVE INGREDIENT495W7451VQCOUGH TABS FOR DOGS AND CATS (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) TABLET [CREATIVE SCIENCE LLC]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCOUGH TABS FOR DOGS AND CATS (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) TABLET [CREATIVE SCIENCE LLC]2
GUAIFENESINACTIVE MOIETY495W7451VQCOUGH TABS FOR DOGS AND CATS (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) TABLET [CREATIVE SCIENCE LLC]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4COUGH TABS FOR DOGS AND CATS (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) TABLET [CREATIVE SCIENCE LLC]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCOUGH TABS FOR DOGS AND CATS (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) TABLET [CREATIVE SCIENCE LLC]2
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPCOUGH TABS FOR DOGS AND CATS (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) TABLET [CREATIVE SCIENCE LLC]2
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MCOUGH TABS FOR DOGS AND CATS (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) TABLET [CREATIVE SCIENCE LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30COUGH TABS FOR DOGS AND CATS (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) TABLET [CREATIVE SCIENCE LLC]2
POVIDONEINACTIVE INGREDIENTFZ989GH94ECOUGH TABS FOR DOGS AND CATS (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) TABLET [CREATIVE SCIENCE LLC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCOUGH TABS FOR DOGS AND CATS (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) TABLET [CREATIVE SCIENCE LLC]2

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 113 · 2,243 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.c1f9ec75-7eb2-405c-8cdc-097cbf2cf87d2026-08-26WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
robafen dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINPreferred Pharmaceuticals Inc.5b2fd5ce-56ab-491a-81b9-44e35a5d23162026-08-26WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Childrens TYLENOL COLD plus COUGH plus RUNNY NOSEACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC5b95905e-b729-4caf-921a-fc4ef815289c2026-08-25WarningsExact identifier
unii: 9D2RTI9KYH
mucus dmDEXTROMETHORPHAN HBR, GUAIFENESINHyVee Inc6bce66d6-e76a-4273-aff9-7ee6adc189802026-08-25WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
good neighbor pharmacy mucus dmDEXTROMETHORPHAN HBR, GUAIFENESINAmerisource Bergenf7925a6b-7029-4389-bf1b-8c0f5e79b9502026-08-25WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
DG health mucus dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDolgencorp Inca95401cc-349e-435a-b953-4d8fd1f547442026-08-24WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Curist Mucus Relief Maximum StrengthGUAIFENESINLittle Pharma, Inc.c7d1136c-a712-2ac5-e053-2995a90a4dd42026-08-24WarningsExact identifier
unii: 495W7451VQ
GOOD NEIGHBOR PHARMACY MUCUS DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINAmerisource Bergenf0aea945-1c18-4c6f-a7d1-6d56624011bb2026-08-24WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.9be8437c-6053-4ed4-bdd2-97f556b5289e2026-08-24WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
DG HEALTH MULTI SYMPTOM SEVERE COLDACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, LLC47ddbb0d-0823-4817-9c56-e7fff77d601c2026-08-21WarningsExact identifier
unii: 9D2RTI9KYH
Mucus Relief DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINDOLGENCORP, LLC5be4e730-3cd6-414e-a23b-f6cad80887502026-08-21WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Mucus Relief DM Cough Maximum StrengthDEXTROMETHORPHAN HBR AND GUAIFENESINCardinal Health 110, LLC. DBA Leader6304a581-9238-4539-b157-293fc05c173e2026-08-21WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
cough dmDEXTROMETHORPHAN POLISTIREXAmazon.com Services LLC10f51748-17b1-459d-8cc6-acc4577290aa2026-08-20WarningsExact identifier
unii: 9D2RTI9KYH
HyVee Nighttime Severe Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHyVee Inc49818610-bf4a-fb86-e063-6294a90ae5982026-08-20WarningsExact identifier
unii: 9D2RTI9KYH
HyVee Daytime Severe Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEHyVee Inc496ec389-1aea-f202-e063-6394a90ae51c2026-08-20WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
CVS Adult Mucus chest congestionGUAIFENESINCVS PHARMACYbec04049-03b2-4465-9cf5-0ad2ef8014ef2026-08-19WarningsExact identifier
unii: 495W7451VQ
CVS Childrens Cough ReliefDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINCVS PHARMACY, INCfe12f3bd-3237-42d1-aec5-c831b96371752026-08-19WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
CVS Maximum Strength Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY, INCbfb3d021-f65f-499c-bbb1-c1aceb7a7bf92026-08-19WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
CVS Long Acting CoughDEXTROMETHORPHAN HBRCVS PHARMACY, INC31a7c0e2-af1c-45dd-8a93-e0879cae60052026-08-19WarningsExact identifier
unii: 9D2RTI9KYH
equate childrens cold coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEWALMART INC.24758ab0-ba08-4b4a-9861-449612bdb89c2026-08-19WarningsExact identifier
unii: 9D2RTI9KYH

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.