FDA.reportPublic FDA data

NDC 0145-0630-61 - Sarna

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
0145-0630
Requested NDC
0145-0630-61
Package NDCs from labels
0145-0630-05, 0145-0630-61, 0145-0630-62
Manufacturer
Stiefel Laboratories, Inc | KIK HOLDCO COMPANY INC.
Effective date
2019-01-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Drug FactsStiefel Laboratories, Inc | KIK HOLDCO COMPANY INC.2019-01-23HUMAN OTC DRUG LABEL
Drug FactsPhysicians Total Care, Inc.2012-09-11HUMAN OTC DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0145-0630-05ML - Milliliter0145-0630b58bce68-b736-4603-a605-ab9d800e105212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5SARNA (PRAMOXINE HYDROCHLORIDE) LOTION [STIEFEL LABORATORIES, INC]8
PRAMOXINEACTIVE MOIETY068X84E056SARNA (PRAMOXINE HYDROCHLORIDE) LOTION [STIEFEL LABORATORIES, INC]8
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHSARNA (PRAMOXINE HYDROCHLORIDE) LOTION [STIEFEL LABORATORIES, INC]8
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27ESARNA (PRAMOXINE HYDROCHLORIDE) LOTION [STIEFEL LABORATORIES, INC]8
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSARNA (PRAMOXINE HYDROCHLORIDE) LOTION [STIEFEL LABORATORIES, INC]8
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OSARNA (PRAMOXINE HYDROCHLORIDE) LOTION [STIEFEL LABORATORIES, INC]8
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4SARNA (PRAMOXINE HYDROCHLORIDE) LOTION [STIEFEL LABORATORIES, INC]8
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSSARNA (PRAMOXINE HYDROCHLORIDE) LOTION [STIEFEL LABORATORIES, INC]8
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RSARNA (PRAMOXINE HYDROCHLORIDE) LOTION [STIEFEL LABORATORIES, INC]8
PEG-8 STEARATEINACTIVE INGREDIENT2P9L47VI5ESARNA (PRAMOXINE HYDROCHLORIDE) LOTION [STIEFEL LABORATORIES, INC]8
PETROLATUMINACTIVE INGREDIENT4T6H12BN9USARNA (PRAMOXINE HYDROCHLORIDE) LOTION [STIEFEL LABORATORIES, INC]8
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ISARNA (PRAMOXINE HYDROCHLORIDE) LOTION [STIEFEL LABORATORIES, INC]8
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSARNA (PRAMOXINE HYDROCHLORIDE) LOTION [STIEFEL LABORATORIES, INC]8
WATERINACTIVE INGREDIENT059QF0KO0RSARNA (PRAMOXINE HYDROCHLORIDE) LOTION [STIEFEL LABORATORIES, INC]8
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5SARNA (PRAMOXINE HYDROCHLORIDE) LOTION [PHYSICIANS TOTAL CARE, INC.]1
PRAMOXINEACTIVE MOIETY068X84E056SARNA (PRAMOXINE HYDROCHLORIDE) LOTION [PHYSICIANS TOTAL CARE, INC.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHSARNA (PRAMOXINE HYDROCHLORIDE) LOTION [PHYSICIANS TOTAL CARE, INC.]1
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27ESARNA (PRAMOXINE HYDROCHLORIDE) LOTION [PHYSICIANS TOTAL CARE, INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSARNA (PRAMOXINE HYDROCHLORIDE) LOTION [PHYSICIANS TOTAL CARE, INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OSARNA (PRAMOXINE HYDROCHLORIDE) LOTION [PHYSICIANS TOTAL CARE, INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4SARNA (PRAMOXINE HYDROCHLORIDE) LOTION [PHYSICIANS TOTAL CARE, INC.]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSSARNA (PRAMOXINE HYDROCHLORIDE) LOTION [PHYSICIANS TOTAL CARE, INC.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9USARNA (PRAMOXINE HYDROCHLORIDE) LOTION [PHYSICIANS TOTAL CARE, INC.]1
POLYOXYL 100 STEARATEINACTIVE INGREDIENTYD01N1999RSARNA (PRAMOXINE HYDROCHLORIDE) LOTION [PHYSICIANS TOTAL CARE, INC.]1
POLYOXYL 8 STEARATEINACTIVE INGREDIENT2P9L47VI5ESARNA (PRAMOXINE HYDROCHLORIDE) LOTION [PHYSICIANS TOTAL CARE, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ISARNA (PRAMOXINE HYDROCHLORIDE) LOTION [PHYSICIANS TOTAL CARE, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSARNA (PRAMOXINE HYDROCHLORIDE) LOTION [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSARNA (PRAMOXINE HYDROCHLORIDE) LOTION [PHYSICIANS TOTAL CARE, INC.]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 2 of 79 · 1,573 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Intense Therapy Lip Balm Mango and MandarinSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC8c55d1cd-cdd6-468b-8a17-b940c62101162026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Jack Black Intensive Therapy Lip Balm Mango Chili LimeAVOBENZONE, OCTINOXATE LIP BALM SUNSCREENJack Black, LLC51349d57-b14d-4798-8d68-03fbe3713d1e2026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Jack Black Intense Thearpy Lip Balm SPF25, Lemon and Shea ButterLIP BALM SUNSCREENJack Black, LLC518cb17a-fdaa-4a60-93fc-708305366eb82026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Jack Black Lavender Lip Balm 0.25ozLIP BALM SUNSCREENJack Black, L.L.C.e8c6a6d9-1093-41f1-87d5-faf8583d43192026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Gas Relief Mint FlavorSIMETHICONERaritan Pharmaceuticals Inc329388cb-3ca1-4ecb-8b50-b1f9e00525592026-09-08WarningsExact identifier
unii: 92RU3N3Y1O
Clear Anti ItchPRAMOXINE HCL, ZINC ACETATEUnited Natural Foods, Inc. dba UNFI242adc68-f9e0-4f69-a580-a107d1634b502026-09-04Warnings, Adverse reactionsExact identifier
unii: 88AYB867L5
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 88AYB867L5
Simethicone 125MG Gas ReliefSIMETHICONE 125 MGOne2Zee Limited Liability Company0df348bf-5a07-4f36-ae70-ca2961a9ce7e2026-09-04WarningsExact identifier
unii: 92RU3N3Y1O
anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONERite Aid Corporation8e954f86-bc15-45e2-9274-ca5d8a7c96872026-09-04WarningsExact identifier
unii: 92RU3N3Y1O
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
unii: 4T6H12BN9U
unii: 88AYB867L5
Infants Gas Relief DropsSIMETHICONEDOLGENCORP INC6b132ac0-e8eb-4199-85ad-5976558ee9c82026-09-03WarningsExact identifier
unii: 92RU3N3Y1O
DG HEALTH Liquid Antacid plus Anti GasCALCIUM CARBONATE, MAGNESIUM HYDROXIDE AND SIMETHICONEDOLGENCORP, LLC8ecb4418-e647-49b5-b418-1c63bb3e5a3c2026-09-03WarningsExact identifier
unii: 92RU3N3Y1O
First Aid AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCLWalgreen Companyb982091a-5aa0-4bbc-bb1d-08016f6d0a702026-09-03WarningsExact identifier
unii: 88AYB867L5
Petroleum Skin ProtectantWHITE PETROLATUMYour Military Exchanges1a0aed14-8606-4676-b4b5-23dd415d43ac2026-09-02Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Simethicone DropsSIMETHICONE DROPSEverpharm LLC5a6d2c1f-4067-969f-e063-6394a90aa83f2026-09-02WarningsExact identifier
unii: 92RU3N3Y1O
TEENY TUMMY Gas Relief DropsSIMETHICONEAkron Pharmadcdd0daf-5ef0-4cb2-872d-89ed6e9f6d602026-09-01WarningsExact identifier
unii: 92RU3N3Y1O
Aloetouch Protect Fragrance FreeDIMETHICONEMedline Industries, LP81f0071b-2bf3-455b-9e5d-8f3ca20adcdf2026-09-01WarningsExact identifier
unii: 92RU3N3Y1O
SILICONE SCARDIMETHICONEHaikou Flash Purchase Star Cross-Border Trade Co., Ltd.5a7727d1-09d1-3cb3-e063-6294a90a1bc52026-09-01WarningsExact identifier
unii: 92RU3N3Y1O
Kroger Extra StrengthSIMETHICONE ANTIGASKROGER COMPANY67ddce93-4d68-4280-bf8b-337b91ab8c8f2026-09-01WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONEUnited Natural Foods, Inc. dba UNFI011859d8-3d0f-4ca7-a98b-4150054154dc2026-09-01WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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