Renovating Regenerating Moisturizing Cream

Product NDC
20151-086
11-digit product format
201510086
Labeler code
20151
Product ID
20151-086_4932579f-4ee4-143a-e054-00144ff88e88
Type
HUMAN OTC DRUG
Nonproprietary name
Glycerin
Dosage form
CREAM
Route
TOPICAL
Labeler
Casmara Cosmetics, SA
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2017-02-23
Marketing end
0000-00-00
Substance
GLYCERIN
Active strength
8 mg/mL
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct20151-086IInactivated by FDA2026-07-31
excluded packagepackage20151-08620151-086-02IInactivated by FDA2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AstringentCALCIUM ACETATE MONOHYDRATE AND ALUMINUM SULFATE TETRADECAHYDRATEGranulation Technology, Inc.1c2bf19c-2f32-4a22-a371-16cc744dce762025-06-12WarningsExact identifier
PetrolatumPETROLATUMGreenbrier International, Inc.91f24a0c-276f-4962-8da8-462b1f42040e2019-05-17WarningsExact identifier
Eczema Care Moisturizing 3 oz.COLLOIDAL OATMEALRejoice International Inc.83967d26-159a-e95c-e053-2991aa0af53a2019-03-08WarningsExact identifier
Oatmeal Skin Relief Calming . 8ozDIMETHICONERejoice International Inc.8384dc52-ba36-da3d-e053-2a91aa0a4f402019-03-07WarningsExact identifier
PetrolatumPETROLATUMGreenbrier International, Inc.b8832ee7-3e13-456b-b301-dad7473a032b2019-02-04WarningsExact identifier
BURTS BEES BABY BEE DIAPER RASHZINC OXIDEBURT'S BEES, INC.168b31b1-9260-61f8-e054-00144ff8d46c2018-12-21WarningsExact identifier
Balmex Diaper RashZINC OXIDERandob Labs,Ltd.f202dd0e-7c61-4ea1-a5f6-e90898366ba32018-11-13WarningsExact identifier
BALMEX ADULT CARE RASHZINC OXIDERandob Labs,Ltd.9443a987-c7b2-4b0d-a9dc-02233135af812018-11-13WarningsExact identifier
BALMEX MULTI-PURPOSEPETROLATUMRandob Labs,Ltd.83a9ba1a-b708-47e2-a4a3-ef847e1bb7922018-11-13WarningsExact identifier
Natures Choice Vitamins A and DA AND D OINTMENTUnipack, Inc.17861122-2231-4a54-b3d8-894153c708d72018-01-15WarningsExact identifier
MG217 Eczema FaceCOLLOIDAL OATMEALWisconsin Pharmacal Company5f10697e-7f0c-f2b7-e053-2991aa0aabde2017-11-30WarningsExact identifier
MG217 Baby EczemaCOLLOIDAL OATMEALWisconsin Pharmacal Company5d65052d-2972-544d-e053-2a91aa0afa3e2017-11-28WarningsExact identifier
Vitamin A and DLANOLIN AND PETROLATUMFamily Dollar Services Inc4826b36d-3326-4f5c-8b22-c5ff79e550622017-11-08WarningsExact identifier
TriCalm HydrogelALUMINUM ACETATEModular Thermal Technologies LLC Dba Life Wear Technologies5cb42ffb-3655-4c38-bf84-1cf33c82df102017-03-23WarningsExact identifier
CVS Health Diaper RashZINC OXIDECVS Health12f786a0-0960-4b98-9f0b-dcf3725a98662017-03-20WarningsExact identifier
ARGAN AIR WATER BANG ESSENCEDIMETHICONEPioom Cosmetic Co.,ltd34e79668-0710-5753-e054-00144ff88e882016-06-08WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For external use only When using this product Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Do not cover compress or wet dressing with plastic to prevent evaporation In some skin conditions, soaking too long may overdry Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
20151-086-022020-01-31C16284748780-19d75b9d0-557e-f424-e053-dadaa90a57ceRenovating Regenerating Moisturizing Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
20151-086-01Renovating Regenerating Moisturizing Cream50 mL in 1 BOTTLE, DISPENSINGCREAM503
20151-086-02Renovating Regenerating Moisturizing Cream1 in 1 BOTTLE, DISPENSINGCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
20151-086RENOVATING REGENERATING MOISTURIZING CREAM (GLYCERIN) CREAM [CASMARA COSMETICS, SA]3Legacy NDC, 2 package rows20170223_32b79573-b448-7199-e054-00144ff8d46c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
20151-086-012015100860150 mL in 1 BOTTLE, DISPENSING50 mlHistorical
20151-086-02201510086021 in 1 BOTTLE, DISPENSINGHistorical