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 5 of 116 · 2,301 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Oil/White PetrolatumMINERAL OIL/WHITE PETROLATUMYYBA CORP5967ef02-6770-bfd7-e063-6294a90a79042026-08-19WarningsExact identifier
unii: T5L8T28FGP
CVS Adult Mucus plus Chest CongestionGUAIFENESINCVS PHARMACY3cf425bd-9d90-4c19-a4f7-3cf7bd0b393a2026-08-19WarningsExact identifier
unii: 495W7451VQ
CVS ADULT COUGH PLUS CHEST CONGESTION DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINCVS PHARMACY4490a7e1-d5b9-459c-8751-c244868079812026-08-19WarningsExact identifier
unii: 495W7451VQ
CVS Adult Cough plus Chest Congestion DM Max with HoneyDEXTROMETHORPHAN HBR, GUAIFENESINCVS PHARMACY822d5bf6-8841-4b7f-bbf7-90c3d50b80242026-08-19WarningsExact identifier
unii: 495W7451VQ
nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLAmazon.com Services LLC2517b241-c433-440f-999d-5a32d5bbaa262026-08-19WarningsExact identifier
unii: 04JA59TNSJ
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.e1a7ab4b-0afe-4463-a039-5be0323cf2f72026-08-19Warnings, Adverse reactionsExact identifier
unii: 04JA59TNSJ
CVS Maximum Strength Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCLCVS PHARMACYe1c246a4-7a8c-4761-ab26-13b5165029cc2026-08-19WarningsExact identifier
unii: 04JA59TNSJ
unii: 495W7451VQ
rugby cough syrupDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINRugby Laboratories89752c69-25c8-45e3-9021-f81b35b52d362026-08-19WarningsExact identifier
unii: 495W7451VQ
CVS Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESINCVS PHARMACY3148f80f-8a0d-4b6c-85be-79085fc044442026-08-19WarningsExact identifier
unii: 495W7451VQ
CVS Childrens Nighttime Multi Symptom ColdACETAMINOPHEN , DIPHENHYDRAMINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY9b244ac8-4ca7-43a0-b328-88f15f0fcc9d2026-08-19WarningsExact identifier
unii: 04JA59TNSJ
CVSCHILDRENS STUFFY NOSE AND COLDCVS PHARMACY, INC6cff265d-94a3-4617-a366-fe970d97f05a2026-08-19WarningsExact identifier
unii: 04JA59TNSJ
unii: 495W7451VQ
CVS Severe Congestion and Pain ReliefACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECVS5a8e4320-bae1-4831-b66b-9babfe8888d62026-08-19WarningsExact identifier
unii: 04JA59TNSJ
unii: 495W7451VQ
CVS Mucus Relief DM Maximum StrengthDEXTROMETHORPHAN HBR AND GUAIFENESINCVS PHARMACY0ae0c244-e019-4b35-890c-8e15e3d3f7ce2026-08-19WarningsExact identifier
unii: 495W7451VQ
Good Sense Tussin DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINL. Perrigo Companyd2541ef0-a73c-43aa-91ff-fdbce2748c4f2026-08-18WarningsExact identifier
unii: 495W7451VQ
CVS Daytime Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCLCVS PHARMACY558b7ed6-a9f6-452c-90cd-df8258663bf12026-08-18WarningsExact identifier
unii: 04JA59TNSJ
unii: 495W7451VQ
Extra Strength NasalPHENYLEPHRINE HYDROCHLORIDECVS PHARMACY7acf1a9a-bd97-48bb-8025-ac26070378a22026-08-18WarningsExact identifier
unii: 04JA59TNSJ
Polytussin DMDEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, PYRILAMINE MALEATEPoly Pharmaceuticals, Inc.fda8f594-82bf-1781-e053-6294a90ad3442026-08-18WarningsExact identifier
unii: 04JA59TNSJ
Mucinex Fast-Max DM Max Honey and Berry FlavorDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINReckitt Benckiser LLCda1f1ef9-a974-4998-8e1d-c1d9995969432026-08-18WarningsExact identifier
unii: 495W7451VQ
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: FZ989GH94E
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: FZ989GH94E

Reported adverse events (FAERS/openFDA)#

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