FDA.reportPublic FDA data

Skin Protectant for Babies and kids

Product NDC
13709-352
11-digit product format
137090352
Labeler code
13709
Product ID
13709-352_448b70db-ca82-db7b-e063-6294a90a5f0d
Type
HUMAN OTC DRUG
Nonproprietary name
Skin Protectant Ointment
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Neilmed Pharmaceuticals Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-02
Substance
LANOLIN; PETROLATUM
Active strength
155; 534 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Skin Protectant for Babies and kids
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LANOLIN155 mg/g
PETROLATUM534 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7EV65EAW6HInternal UNII lookup
4T6H12BN9UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
664981Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
448b70db-ca81-db7b-e063-6294a90a5f0dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13709-352-01Skin Protectant for Babies and kids1 in 1 CARTONOINTMENT11
13709-352-01Skin Protectant for Babies and kids113 g in 1 TUBEOINTMENT1131

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 31 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pediadermics eczema 3COLLOIDAL OATMEAL, DIMETHICONERenu Laboratories, LLCaf861f0b-4387-6861-e053-2995a90a8bfa2025-12-02WarningsExact identifier
application number: M016
Flexitol Face and Eyelid EczemaOATMEALLaCorium Health USA Inc.f5b24f9c-1a77-4dc3-b7fd-ccad7b06ee652025-12-02WarningsExact identifier
application number: M016
ProCure HydroShieldPETROLATUM 41%Twin Med LLC3d36e664-ac10-72eb-e063-6294a90a49c42025-12-01WarningsExact identifier
application number: M016
ProCure Vitamin A and DWHITE PETROLATUM 93.4%Twin Med LLC3d385a07-2a12-fce7-e063-6294a90a32d62025-12-01WarningsExact identifier
application number: M016
ESTRIOLESTRIOLShenzhen Mengyue Technology Co., Ltd.44de9eb4-080e-bfbc-e063-6394a90ac0ea2025-12-01WarningsExact identifier
application number: M016
CareALL Creamy Petroleum JellyPETROLATUMNew World Imports, Ince13fea4e-bd6d-425a-aa7e-1d41dc36bf002025-12-01WarningsExact identifier
application number: M016
CareALL Creamy Cocoa Butter Petroleum JellyPETROLATUMNew World Imports, Inc9358b8ef-df14-45fc-9bfd-9052577a1f882025-12-01WarningsExact identifier
application number: M016
CAREALL Zinc OxideZINC OXIDENew World Imports Incaa9ae4d1-4229-4894-9eaf-8588b28674722025-12-01WarningsExact identifier
application number: M016
CAREALL PetroleumPETROLATUMNew World Imports, Inc47e999de-08bd-4121-b6d0-270cc603b56d2025-12-01WarningsExact identifier
application number: M016
HOEGOA Growth Hair SerumGLYCERINShantou Oralhoe Biotechnology Co., Ltd.44b6609f-c58b-b6ac-e063-6394a90a749b2025-11-29WarningsExact identifier
application number: M016
OUHOE Micro Darts Tag gone PatchGLYCERINShantou Ouhoe Technology Co., Ltd.33ce447c-facd-35fb-e063-6394a90a1ead2025-11-27WarningsExact identifier
application number: M016
OUHOE Herbal Hair OilGLYCERINShantou Ouhoe Technology Co., Ltd.30c3df30-e0c6-4efa-e063-6294a90ac40a2025-11-27WarningsExact identifier
application number: M016
OUHOE Aloe Soothing Sun CreamGLYCERINShantou Ouhoe Technology Co., Ltd.326781e0-55dc-80fc-e063-6394a90a09aa2025-11-27WarningsExact identifier
application number: M016
OUHOE Ultra Anti-Acne Control GelGLYCERINShantou Ouhoe Technology Co., Ltd.3bd1b734-76b0-5264-e063-6294a90a32d02025-11-27WarningsExact identifier
application number: M016
OUHOE Lipoma CreamGLYCERINShantou Ouhoe Technology Co., Ltd.3cb4aed1-3b13-a62a-e063-6294a90a6c392025-11-27WarningsExact identifier
application number: M016
OUHOE Para CrescimentoGLYCERINShantou Ouhoe Technology Co., Ltd.42fbfcac-29ab-51f7-e063-6394a90a626f2025-11-27WarningsExact identifier
application number: M016
OUHOE Biotin With Hydrolyzed CollagenGLYCERINShantou Ouhoe Technology Co., Ltd.43138915-5fe1-6e32-e063-6294a90abefa2025-11-27WarningsExact identifier
application number: M016
EELHOE Pain Relief PatchGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.3f835843-eb04-6273-e063-6294a90ab2f02025-11-27WarningsExact identifier
application number: M016
EELHOE Skin Tag RemoverGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.32922508-74ae-8347-e063-6294a90a61542025-11-27WarningsExact identifier
application number: M016
EELHOE Bodyacne Removal CleanserGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.3bbebf1d-2e22-1427-e063-6294a90a79992025-11-27WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
664981lanolin 15.5 % / petrolatum 53.4 % Topical OintmentPSN448b70db-ca81-db7b-e063-6294a90a5f0d1
664981lanolin 0.155 MG/MG / petrolatum 0.534 MG/MG Topical OintmentSCD448b70db-ca81-db7b-e063-6294a90a5f0d1
664981lanolin 15.5 % / petrolatum 53.4 % Topical OintmentSY448b70db-ca81-db7b-e063-6294a90a5f0d1
664981lanolin 15.5 GM per 100 GM / petrolatum 53.4 GM per 100 GM Topical OintmentSY448b70db-ca81-db7b-e063-6294a90a5f0d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
13709-352-01137090352011 TUBE in 1 CARTON (13709-352-01) / 113 g in 1 TUBE1 tube2026-01-02NoNoCurrent