NDC 61328-101

12 Hour Miracle

Allantoin

12 Hour Miracle is a Topical Ointment in the Human Otc Drug category. It is labeled and distributed by Skinfix, Inc.. The primary component is Allantoin.

Product ID61328-101_d413fcc5-de80-4040-9608-135a5434f4fb
NDC61328-101
Product TypeHuman Otc Drug
Proprietary Name12 Hour Miracle
Generic NameAllantoin
Dosage FormOintment
Route of AdministrationTOPICAL
Marketing Start Date2015-05-23
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart347
Labeler NameSkinfix, Inc.
Substance NameALLANTOIN
Active Ingredient Strength1 g/100g
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 61328-101-51

1 TUBE in 1 BOX (61328-101-51) > 60 g in 1 TUBE (61328-101-11)
Marketing Start Date2015-05-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61328-101-51 [61328010151]

12 Hour Miracle OINTMENT
Marketing CategoryOTC monograph final
Application Numberpart347
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-05-23
Marketing End Date2020-01-03

NDC 61328-101-11 [61328010111]

12 Hour Miracle OINTMENT
Marketing CategoryOTC monograph final
Application Numberpart347
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-05-23
Marketing End Date2020-01-03

NDC 61328-101-10 [61328010110]

12 Hour Miracle OINTMENT
Marketing CategoryOTC monograph final
Application Numberpart347
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-03-15
Marketing End Date2020-01-03

NDC 61328-101-12 [61328010112]

12 Hour Miracle OINTMENT
Marketing CategoryOTC monograph final
Application Numberpart347
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-03-15
Marketing End Date2020-01-03

Drug Details

Active Ingredients

IngredientStrength
ALLANTOIN.5 g/100g

OpenFDA Data

SPL SET ID:c8ee66c9-6d30-49ad-9965-12692551ead4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1044541
  • NDC Crossover Matching brand name "12 Hour Miracle" or generic name "Allantoin"

    NDCBrand NameGeneric Name
    61328-10112 Hour Miracle12 Hour Miracle
    61328-12012 Hour Miracle12 Hour Miracle
    52342-001Anti Chafe BalmAllantoin
    44019-400Baby Wipes with AllantoinALLANTOIN
    44781-130BIOWHITE BEAUTY SERUMALLANTOIN
    42021-036Body ArmorAllantoin
    15197-007Bodyglide anti chafe balmAllantoin
    15197-009Bodyglide For HerAllantoin
    51483-002Burn-B Gone OTCAllantoin
    0299-4103Cetaphil Baby Soothe and Protect Creamallantoin
    0299-4105Cetaphil Soothing Gel Creamallantoin
    15197-008Chamois GlideAllantoin
    11084-042Cool MelonAllantoin
    10738-301DIABETIC BRUISE DEFENSEALLANTOIN
    43948-5001Dr Young 2p Blemish Base SPF35 PAALLANTOIN
    52891-103DR. OBERON NATURAL BABYallantoin
    43948-1101Dr. Young 2P Pearl Brightening Balm SPF35 PAALLANTOIN
    49035-838Equate ScarAllantoin
    42387-300Grahams Natural Eczema Gelallantoin
    51270-116Hasol Revitalizing Scalp AmpouleALLANTOIN
    45156-5616Inflammation OTCAllantoin
    51985-010IONTOPHORESISALLANTOIN
    0259-1105Mederma Advanced ScarAllantoin
    0259-1101Mederma for KidsAllantoin
    51346-218ORIGINAL POWER REFIRMING AMPOULEAllantoin
    51346-219ORIGINAL POWER WHITENING AND LINELESS AMPOULEALLANTOIN
    52123-050PURE RED RED GINSENG CLEANSINGAllantoin
    24474-001Run Guard OriginalALLANTOIN
    24474-002Run Guard SensitiveALLANTOIN
    52319-001Sarene Soothing SkinAllantoin
    11084-040SBS 40Allantoin
    11084-240SBS 40Allantoin
    11084-241SBS 40 Medicated CreamAllantoin
    11084-141SBS 41 Medicated CreamAllantoin
    11084-089SBS CareAllantoin
    49967-783SkinCeuticals Advanced Scar Control Skin ProtectantAllantoin
    50795-2001U-max Multi BBALLANTOIN
    50795-3001U-max Whitening Functional EssenceALLANTOIN
    11673-700Up and Up Advanced ScarALLANTOIN
    54111-113YES to coconutALLANTOIN

    Trademark Results [12 Hour Miracle]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    12 HOUR MIRACLE
    12 HOUR MIRACLE
    86753108 5067063 Live/Registered
    Skinfix Inc.
    2015-09-10

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.