FDA.reportPublic FDA data

NDC 37012-077-50 - Skopko Chest Congestion Relief PE PE

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
37012-077
Requested NDC
37012-077-50
Package NDCs from labels
37012-077-50, 37012-077-01
Manufacturer
Shopko | Reese Pharmaceutical Co
Effective date
2013-07-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Skopko Chest Congestion Relief PE PE - Shopko | Reese Pharmaceutical CoShopko | Reese Pharmaceutical Co2013-07-02HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37012-077-012020-01-31C16284748780-19d75b9d0-ee6c-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37012-077-01Skopko Chest Congestion Relief PEPE1 in 1 CARTONTABLET11
37012-077-50Skopko Chest Congestion Relief PEPE50 in 1 BOTTLE, PLASTICTABLET501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37012-077SKOPKO CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [SHOPKO]1Legacy NDC, 2 package rows20130704_10874e99-e7fa-4994-9af8-7e203262b1cc.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GuaifenesinACTIVE INGREDIENT495W7451VQSKOPKO CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [SHOPKO]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJSKOPKO CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [SHOPKO]1
GuaifenesinACTIVE MOIETY495W7451VQSKOPKO CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [SHOPKO]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVSKOPKO CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [SHOPKO]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USKOPKO CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [SHOPKO]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SKOPKO CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [SHOPKO]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GSKOPKO CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [SHOPKO]1
MAGNESIUM SILICATEINACTIVE INGREDIENT9B9691B2N9SKOPKO CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [SHOPKO]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SKOPKO CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [SHOPKO]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DSKOPKO CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [SHOPKO]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPSKOPKO CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [SHOPKO]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ESKOPKO CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [SHOPKO]1

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 8 of 116 · 2,301 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RIGHT REMEDIES Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINStrive Pharmaceuticals Inc.51c4dcfb-8725-d547-e063-6394a90ac04c2026-07-31WarningsExact identifier
unii: 495W7451VQ
StonarhiniCHLORPHENIRAMINE MALEATE, PHENYLEPHRINESato Pharmaceutical Co., Ltd.cc353280-0b4c-418c-93fe-8501259550092026-07-31WarningsExact identifier
unii: 04JA59TNSJ
VedlubeMINERAL OIL AND WHITE PETROLATUM LUBRICANT EYE OINTMENTVEDCO INC55d126fa-7489-4307-824e-b6957e57d4e92026-07-31WarningsExact identifier
unii: T5L8T28FGP
Rugby Mucus Relief DM ERDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINRugby Laboratoriesf2629794-4845-4ca6-8668-a21a56f182cb2026-07-30WarningsExact identifier
unii: 495W7451VQ
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDELifestar Pharma LLC1767c4b7-36a0-4e64-9091-2af22161402f2026-07-30Warnings, Adverse reactionsExact identifier
unii: 04JA59TNSJ
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar Services Incce590997-3cae-4f22-ac39-2b14d39494bc2026-07-30WarningsExact identifier
unii: 04JA59TNSJ
unii: 495W7451VQ
up and up mucus relief dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINTarget Corporation9cb3719b-44bc-4ad1-a9c5-e6cc047f4d0e2026-07-30WarningsExact identifier
unii: 495W7451VQ
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDELifestar Pharma LLCf43e4abd-0083-4fe5-9c27-0ba9245e51382026-07-30Warnings, Adverse reactionsExact identifier
unii: 04JA59TNSJ
up and upPHENYLEPHRINE HYDROCHLORIDETarget Corporationb42775ae-44fe-487e-b9ca-21d9687020a92026-07-29WarningsExact identifier
unii: 04JA59TNSJ
RUGBY MUCUS RELIEF DM ERDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINRugby Laboratories8090d561-0478-435d-ad6f-2334e1823bc32026-07-28WarningsExact identifier
unii: 495W7451VQ
Exchange Select Mucus DMDEXTROMETHORPHAN HBR, GUAIFENESINArmy & Air Force Exchange Service99a11bea-8cf5-4c5d-95b1-eaedccaf9e7d2026-07-28WarningsExact identifier
unii: 495W7451VQ
NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd1115a55-35cd-4f20-8872-f42983a5ebcd2026-07-28WarningsExact identifier
unii: 04JA59TNSJ
TUSSINDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINSafewaya5e2bda4-2da6-4c20-855d-2888dadf0c3a2026-07-28WarningsExact identifier
unii: 495W7451VQ
DM MaximumDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDf6029b04-e681-40fc-be4f-14091b76dd4e2026-07-27WarningsExact identifier
unii: 495W7451VQ
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCLWalgreen Company0a48f650-ad2a-4105-9ff4-2bc4d94b46d32026-07-27WarningsExact identifier
unii: 04JA59TNSJ
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company84202ebe-97b6-4be2-bb09-7f2729303f962026-07-27WarningsExact identifier
unii: 04JA59TNSJ
unii: 495W7451VQ
Daytime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation8d41defe-8120-4cbb-b42e-c805cc5a794b2026-07-24WarningsExact identifier
unii: 04JA59TNSJ
unii: 495W7451VQ
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDEProdose, Inc.3afc88c7-388a-dbd9-e063-6294a90a4faf2026-07-24WarningsExact identifier
unii: 04JA59TNSJ
SERYNTH HEMORRHOIDLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD4c667f3d-1238-2f02-e063-6394a90ab7422026-07-24WarningsExact identifier
unii: 04JA59TNSJ
DERMFREE HEMORRHOIDLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD4a5d0e79-d620-0147-e063-6294a90a31032026-07-23WarningsExact identifier
unii: 04JA59TNSJ

Reported adverse events (FAERS/openFDA)#

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