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 3 of 79 · 1,566 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kroger Extra Strength Gas ReliefSIMETHICONE ANTIGASKROGER COMPANY6aa691e4-3179-4cf7-855a-e44f16904c1c2026-09-01WarningsExact identifier
unii: 92RU3N3Y1O
Maximum Strength Betadine ClearBENZALKONIUM CL AND PRAMOXINE HCLAtlantis Consumer Healthcare, Inc.31b94a76-1536-47c0-ab03-e487c2625c582026-08-31WarningsExact identifier
unii: 88AYB867L5
PURE PETROLATUMPETROLATUMVASA COSMETICS PRIVATE LIMITED5a57b197-3e18-b3ab-e063-6394a90aed822026-08-31WarningsExact identifier
unii: 4T6H12BN9U
Infants Gas Relief Dye FreeSIMETHICONE ANTIGASTHE KROGER CO.722c8226-6556-4150-9fda-91be2b31183f2026-08-31WarningsExact identifier
unii: 92RU3N3Y1O
HYDROPHORHYDROPHORAkron Pharma Inc.e6099df7-d418-479a-9d2e-ced523585aed2026-08-28WarningsExact identifier
unii: 4T6H12BN9U
Daily MoisturizingDIMETHICONEYour Military Exchangese7af5488-1c49-41e9-9d8b-d519c61076992026-08-28Warnings, Adverse reactionsExact identifier
unii: 92RU3N3Y1O
GERI-LANTA MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEPreferred Pharmaceuticals Inc.3b049027-30ac-4c78-a4f1-8191f7ed45bf2026-08-27WarningsExact identifier
unii: 92RU3N3Y1O
MedlineDIMETHICONEMedline Industries, LP0d964138-f68d-dbf5-e063-6294a90a83202026-08-27WarningsExact identifier
unii: 92RU3N3Y1O
Extra Strength Gas ReliefSIMETHICONEShield Pharmaceuticals Corp534144be-fcaf-400d-b772-595c62ae6ea62026-08-27WarningsExact identifier
unii: 92RU3N3Y1O
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEGuardian Drug Company48ec50ab-f24b-367b-e063-6294a90ad7362026-08-27WarningsExact identifier
unii: 92RU3N3Y1O
anti diarrheal and anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONECVS Pharmacy065699b5-217e-432f-a253-cea2d3f622332026-08-26WarningsExact identifier
unii: 92RU3N3Y1O
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEKROGER COMPANYb9e61a03-e008-50ab-e053-2a95a90a32102026-08-26WarningsExact identifier
unii: 92RU3N3Y1O
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECVS PHARMACYaf71e02d-e7c7-f925-e053-2995a90a08612026-08-26WarningsExact identifier
unii: 92RU3N3Y1O
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 88AYB867L5
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEPreferred Pharmaceuticals Inc.a96496ff-4b35-4ebe-a6e4-bcfa48fb13412026-08-26WarningsExact identifier
unii: 92RU3N3Y1O
IMODIUM Multi-Symptom ReliefLOPERAMIDE HYDROCHLORIDE AND DIMETHICONEKenvue Brands LLCecb91e47-2b0c-47c8-9256-4623d8bc825e2026-08-25WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONERugby Laboratories9353633b-5718-4366-a943-d49b8076256c2026-08-24WarningsExact identifier
unii: 92RU3N3Y1O
ClaravieDIMETHICONEGentell LLC59c6da39-b5f1-8253-e063-6394a90a0e8f2026-08-24WarningsExact identifier
unii: 92RU3N3Y1O
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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