FDA.reportPublic FDA data

NDC 49035-462-43 - Suphedrine 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
49035-462
Requested NDC
49035-462-43
Package NDCs from labels
49035-462-43, 49035-462-08
Manufacturer
Wal-Mart Stores Inc | LNK International, Inc.
Effective date
2021-10-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Equate 44-462 - DelistedWal-Mart Stores Inc | LNK International, Inc.2021-10-04HUMAN OTC DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-462-08EA - Each49035-4626eb53ed0-d6e0-4904-9272-9640fa5901cd12013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZSUPHEDRINE PE (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET [WAL-MART STORES INC]6
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJSUPHEDRINE PE (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET [WAL-MART STORES INC]6
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965USUPHEDRINE PE (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET [WAL-MART STORES INC]6
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVSUPHEDRINE PE (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET [WAL-MART STORES INC]6
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKSUPHEDRINE PE (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET [WAL-MART STORES INC]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUPHEDRINE PE (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET [WAL-MART STORES INC]6
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SUPHEDRINE PE (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET [WAL-MART STORES INC]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SUPHEDRINE PE (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET [WAL-MART STORES INC]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SUPHEDRINE PE (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET [WAL-MART STORES INC]6
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSUPHEDRINE PE (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET [WAL-MART STORES INC]6

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 106 · 2,120 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Maximum Strength Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY, INCbfb3d021-f65f-499c-bbb1-c1aceb7a7bf92026-08-19WarningsExact identifier
unii: 04JA59TNSJ
CVS Childrens Cold plus Cough plus Runny NoseACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDECVS7dc30e46-e289-40fc-b217-b123fee5daee2026-08-19WarningsExact identifier
unii: V1Q0O9OJ9Z
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
CVS childrens Cough and ColdCHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBRCVS PHARMACY035c5e2a-04e3-490b-8f1a-233a5cb6eadb2026-08-19WarningsExact identifier
unii: V1Q0O9OJ9Z
CVS Nighttime Childrens Cold and Cough Multi-Symptom ReliefCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDECVS PHARMACYd66b1a2e-49b6-473b-acec-2694c73ce8b42026-08-19WarningsExact identifier
unii: V1Q0O9OJ9Z
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
CVS Severe Congestion and Pain ReliefACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECVS5a8e4320-bae1-4831-b66b-9babfe8888d62026-08-19WarningsExact identifier
unii: 04JA59TNSJ
CVS Daytime Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCLCVS PHARMACY558b7ed6-a9f6-452c-90cd-df8258663bf12026-08-18WarningsExact identifier
unii: 04JA59TNSJ
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
Cerebellum Thalamus A AurmCEREBELLUM THALAMUS A AURUMUriel Pharmacy Inc.e1c395b8-9221-401f-8980-c91ff88434582026-08-17WarningsExact identifier
unii: ETJ7Z6XBU4
CVS Overnight Cold and Flu Clear and CoolACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDECVS PHARMACY, INC2497a011-d7a0-4d69-97e2-bbf25a99b1cc2026-08-17WarningsExact identifier
unii: 04JA59TNSJ
Mucus Relief Cough Cold Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLH E B3ef949f5-ac8c-44be-b04d-6996fa59a94b2026-08-17WarningsExact identifier
unii: 04JA59TNSJ
Sinus PE Head Congestion and MucusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLBetter Living Brands, LLC28a4ec37-11dd-4134-81aa-851f081bf0882026-08-17WarningsExact identifier
unii: 04JA59TNSJ
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leader610accad-2f8b-4605-9357-a58e6e18d4172026-08-15WarningsExact identifier
unii: 04JA59TNSJ
CVS NightTime ColdACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY0f0cc40d-7939-4d4d-a931-b4de4070fea12026-08-14WarningsExact identifier
unii: 04JA59TNSJ
BM BM134 DROPSARSENIC ALBUM, HYDRASTIS, MYRISTICA, NITRIC ACID, PAEONIA, RHUS TOX, SILICEABM Private Limited59023500-89be-cc76-e063-6294a90a6e022026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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