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 3 of 116 · 2,301 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Maximum Strength Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLKROGER COMPANYe1d27123-358f-4b0c-8e3b-33474750a0e62026-09-02WarningsExact identifier
unii: 04JA59TNSJ
unii: 495W7451VQ
Maximum Strength Nighttime Cold and FluACETAMINOPHEN , DIPHENHYDRAMINE HCL,PHENYLEPHRINE HCLTHE KROGER CO058b2021-8a61-40b0-8a2e-a784d2b847fb2026-09-02WarningsExact identifier
unii: 04JA59TNSJ
Daytime Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCLThe Kroger Co.494e69ef-dc9f-4e14-b856-5eaf0f541a032026-09-02WarningsExact identifier
unii: 04JA59TNSJ
unii: 495W7451VQ
Leader Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCardinal Health 110, LLC. dba Leader7c54d128-9da7-49d7-bda4-9d4f7b8bc6522026-09-01WarningsExact identifier
unii: 495W7451VQ
MAX Tussin Cough and Chest Congestion DM Sugar FreeDEXTROMETHORPHAN HBR, GUAIFENESINAkron Pharma Inc.5c4c8115-cec9-4f2c-9ea9-328535e97b072026-09-01WarningsExact identifier
unii: 495W7451VQ
Lidocaine PhenylephrineLIDOCAINE PHENYLEPHRINEYYBA CORP5a72a190-2129-411e-e063-6394a90a08c22026-09-01WarningsExact identifier
unii: 04JA59TNSJ
Daytime Cold and Flu Multi Symptom ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corpe85b4c2a-d4e0-452c-9a08-fcc0ff6eaa212026-08-31WarningsExact identifier
unii: 04JA59TNSJ
Daytime Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corp67849e09-2056-4013-98b1-d003ed3250a22026-08-31WarningsExact identifier
unii: 04JA59TNSJ
MAX Tussin Mucus and Chest Congestion Sugar FreeGUAIFENESINAkron Pharma Inc.3b023b91-e703-4599-9864-96d8c328b45c2026-08-31WarningsExact identifier
unii: 495W7451VQ
MAX Tussin Mucus and Chest CongestionGUAIFENESINAkron Pharma Inc.ac874a31-5556-4669-937f-dcb52aaecd8a2026-08-31WarningsExact identifier
unii: 495W7451VQ
MAX Tussin Cough and Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINAkron Pharma Inc.e0ce4287-bfa1-4413-97c8-4fe2e39bda362026-08-31WarningsExact identifier
unii: 495W7451VQ
Mucinex DMGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDESelect Consumer Group3c9c8fb0-8a00-4b0f-e063-6394a90af6322026-08-30WarningsExact identifier
unii: 495W7451VQ
Tussin DM DaytimeDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED432d4833-2eaf-4f7c-b6b4-41043a6b7e2a2026-08-28WarningsExact identifier
unii: 495W7451VQ
Mineral OilMINERAL OILYour Military Exchanges6025dce6-02e8-418c-a248-0b5c33ff60672026-08-28Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
Multi-Symptom AllergyACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLWalgreen Company5170c450-989d-44fa-ab38-86c78feae3b62026-08-28WarningsExact identifier
unii: 04JA59TNSJ
Maximum Strength Mucus Relief DMGUAIFENESIN AND DEXTROMETHORPHAN HBRWal-Mart Stores, Inc.ff7280e7-804b-423d-add8-54ec2c76fca22026-08-28WarningsExact identifier
unii: 495W7451VQ
Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINWalgreen Companyd8a693f7-03c1-4583-89a8-8d506a894b242026-08-28WarningsExact identifier
unii: 495W7451VQ
Maximum Strength Mucus ReliefDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLHyvee Inc4e578c7a-88d4-e4cd-e063-6394a90aac442026-08-27WarningsExact identifier
unii: 04JA59TNSJ
unii: 495W7451VQ
MUCUS RELIEFGUAIFENESINGeri-Care Pharmaceuticals, Corp5afb242f-fac9-dc81-e063-6394a90a84482026-08-27WarningsExact identifier
unii: 495W7451VQ
Nighttime Cold and Flu Maximum StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCIWalgreens37896933-3ed3-457f-8a32-ee0d784a19e82026-08-27WarningsExact identifier
unii: 04JA59TNSJ

Reported adverse events (FAERS/openFDA)#

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