NDC 42507-384-01 - cough dm

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
42507-384
Requested NDC
42507-384-01
Package NDCs from labels
42507-384-00, 42507-384-21, 42507-384-01, 42507-384-28
Manufacturer
HyVee Inc
Effective date
2026-03-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
cough dm - HyVee IncHyVee Inc2026-03-06HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42507-384-00cough dm89 mL in 1 BOTTLESUSPENSION896
42507-384-01cough dm148 mL in 1 BOTTLESUSPENSION1486
42507-384-21cough dm1 in 1 CARTONSUSPENSION16
42507-384-28cough dm1 in 1 CARTONSUSPENSION16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [HYVEE INC]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [HYVEE INC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [HYVEE INC]2
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [HYVEE INC]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [HYVEE INC]2
POLISTIREXINACTIVE INGREDIENT5H9W9GTW27COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [HYVEE INC]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [HYVEE INC]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ECOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [HYVEE INC]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [HYVEE INC]2
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [HYVEE INC]2
SODIUM POLYSTYRENE SULFONATEINACTIVE INGREDIENT1699G8679ZCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [HYVEE INC]2
SUCROSEINACTIVE INGREDIENTC151H8M554COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [HYVEE INC]2
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [HYVEE INC]2
TRAGACANTHINACTIVE INGREDIENT2944357O2OCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [HYVEE INC]2
TRIACETININACTIVE INGREDIENTXHX3C3X673COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [HYVEE INC]2
WATERINACTIVE INGREDIENT059QF0KO0RCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [HYVEE INC]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [HYVEE INC]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 100 of 117 · 2,328 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ROBITUSSIN COUGH PLUS CHEST CONGESTION DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINHaleon US Holdings LLC4908b326-e1da-44ca-8087-7e41a16c27b02024-04-08WarningsExact identifier
unii: 9D2RTI9KYH
Childrens Robitussin 12 Hour Cough ReliefDEXTROMETHORPHAN POLISTIREXHaleon US Holdings LLC6bcad434-5714-443c-ba83-ed534df9f20a2024-04-08WarningsExact identifier
application number: ANDA091135
rxcui: 1373045
unii: 9D2RTI9KYH
Mucus Relief Cough ChildrensDEXTROMETHORPHAN HBR, GUAIFENSINH E B9ba5ca1b-2e3c-439e-8887-c26f144b88ef2024-04-08WarningsExact identifier
unii: 9D2RTI9KYH
Cold and Flu Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEH E B12ace982-bd47-49b0-ba1b-e0a29d42f1d62024-04-08WarningsExact identifier
unii: 9D2RTI9KYH
Cold and Flu Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEH E Bbd19b1f2-d9d3-4dab-8181-605f769ab62f2024-04-08WarningsExact identifier
unii: 9D2RTI9KYH
Daytime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLH E B9f533092-060c-4379-9a77-ecfea8aa46e12024-04-08WarningsExact identifier
unii: 9D2RTI9KYH
Robitussin Maximum Strength 12 Hour Cough and Mucus ReliefDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINHaleon US Holdings LLC96409b52-b0ec-444b-bc39-fd41070e98552024-04-07WarningsExact identifier
unii: 9D2RTI9KYH
Robitussin Severe Multi-Symptom Cough Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC66360295-f364-479a-8b49-c12b219182792024-04-06WarningsExact identifier
unii: 9D2RTI9KYH
Robitussin Peak Cold Multi-Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC8c0a2424-e8ac-d91c-b46d-a5ee29f919362024-04-06WarningsExact identifier
unii: 9D2RTI9KYH
Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEHaleon US Holdings LLCe7cf7c5d-5c9a-4201-9e30-1cd6160718552024-04-06WarningsExact identifier
unii: 9D2RTI9KYH
Robitussin Medi-SoothersDEXTROMETHORPHAN HYDROBROMIDE, MENTHOLHaleon US Holdings LLC4c3d57e3-e40b-41ca-b44b-5f4c5f4dbae52024-04-06WarningsExact identifier
unii: 9D2RTI9KYH
PREPARATION H Maximum StrengthGLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCLHaleon US Holdings LLC7cc03d2e-e708-589a-d9bb-58ebbda989c02024-04-05WarningsExact identifier
unii: PDC6A3C0OX
DEXTROMETHORPHAN HBR, GUAIFENESINDEXTROMETHORPHAN HBR, GUAIFENESINOPMX LLC9a16e7f3-78aa-0b01-e053-2a95a90ab19c2024-04-05WarningsExact identifier
unii: 9D2RTI9KYH
Theraflu Severe Cold Relief Daytime Honey GingerACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLC44404c6a-8031-4f4b-a48e-3739a11a0d2c2024-04-05WarningsExact identifier
unii: 9D2RTI9KYH
ActivcinACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEOPMX LLC.e06a4d72-cc8d-fd9d-e053-2995a90a7a762024-04-05WarningsExact identifier
unii: 9D2RTI9KYH
Coldtac Plus SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEOPMX LLC.ff5ce5c6-a03f-2ad3-e053-6394a90a99f62024-04-05WarningsExact identifier
unii: 9D2RTI9KYH
Desresfriol-DX SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEOPMX LLC.ff5e0e0f-bfd2-b02b-e053-6394a90afe8a2024-04-05WarningsExact identifier
unii: 9D2RTI9KYH
Eye WashWATERM-star (Hubei) Health&Care Products Co., Ltd.71706039-e250-4f08-9687-71b2928c4e462024-04-01WarningsExact identifier
unii: 059QF0KO0R
Clear Eyes Natural TearsPOLYVINYL ALCOHOL AND POVIDONEPrestige Brands Holdings, Inc.efba3eb0-798d-4635-b19b-4970e45b3cc92024-04-01WarningsExact identifier
unii: FZ989GH94E
DAYTIME COLD AND FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEAdvanced Rx LLC38299cf3-e884-4676-8cc4-6dd64e7d023c2024-03-30WarningsExact identifier
unii: 9D2RTI9KYH

Reported adverse events (FAERS/openFDA)#

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