NDC 53997-100

LANSINOH BABY

Dimethicone

LANSINOH BABY is a Topical Ointment in the Human Otc Drug category. It is labeled and distributed by Lansinoh Laboratories, Inc.. The primary component is Dimethicone; Lanolin; Zinc Oxide.

Product ID53997-100_7368031e-8bdc-4e44-bd74-87b28bcd04e3
NDC53997-100
Product TypeHuman Otc Drug
Proprietary NameLANSINOH BABY
Generic NameDimethicone
Dosage FormOintment
Route of AdministrationTOPICAL
Marketing Start Date2011-01-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart347
Labeler NameLansinoh Laboratories, Inc.
Substance NameDIMETHICONE; LANOLIN; ZINC OXIDE
Active Ingredient Strength4 g/85g; g/85g; g/85g
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 53997-100-01

85 g in 1 TUBE (53997-100-01)
Marketing Start Date2011-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53997-100-01 [53997010001]

LANSINOH BABY OINTMENT
Marketing CategoryOTC monograph final
Application Numberpart347
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-01-01
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
DIMETHICONE4.25 g/85g

OpenFDA Data

SPL SET ID:e299e5c6-86f5-4233-bdd1-53c8306e9cca
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1150463
  • 1441318
  • UPC Code
  • 0044677101004
  • NDC Crossover Matching brand name "LANSINOH BABY" or generic name "Dimethicone"

    NDCBrand NameGeneric Name
    53997-100LANSINOH BABYLANSINOH BABY
    0132-0326Boudreauxs Butt BarrierDimethicone
    0187-2218CeraVeDimethicone
    0187-2219CeraVedimethicone
    0187-2489CeraVedimethicone
    0299-4114Cetaphil Cracked Skin RepairDimethicone
    0299-4115Cetaphil Cracked Skin Repair BalmDimethicone
    0573-1935CHAPSTICK OVERNIGHTdimethicone
    0363-2247Daily BabyDimethicone
    0869-0354Daily BabyDimethicone
    0869-0496Daily BabyDimethicone
    0869-0619Daily MoisturizingDimethicone
    0363-5345Infants Gas ReliefDimethicone
    0363-5773Infants Gas ReliefDIMETHICONE
    0259-2202Mederma PMDimethicone
    0259-2102Mederma Stretch Marks Therapydimethicone
    0093-3204MoisturelDimethicone
    0430-3100MoisturelDimethicone
    10742-7005Softlipsdimethicone
    10742-7002Softlips Cherry, Raspberry, Vanilladimethicone
    10742-7003Softlips Watermelon, Tropical Coconut, Peach Passiondimethicone
    0132-8744Summers Eve Active ChafeDimethicone
    0187-1660TheraSealDimethicone

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