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 28 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TENA PROSKIN BARRIERDIMETHICONEEssity HMS North America Inc118bf2df-ee7b-454f-9c0b-2697dc8262682025-12-21WarningsExact identifier
application number: M016
Geri Care Medicated PadsWITCH HAZELGeri-Care Pharmaceuticals, Corp2d020e79-2bcf-ba8f-e063-6394a90a6fda2025-12-19WarningsExact identifier
application number: M016
After Bite AdvancedSODIUM BICARBONATETender Corporation d/b/a Adventure Ready Brands223d1de8-7940-bbdc-e063-6294a90a51d82025-12-18WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant White Tea and ApricotCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Companyf19ba97d-5c47-e98f-e053-2995a90afc232025-12-18WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Pink GrapefruitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Companyd21c05e4-c4e6-de6e-e053-2995a90a38bb2025-12-18WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Body Skin Protectant Cooling CucumberCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company1a9cc960-782e-4f0c-e063-6394a90a32f62025-12-18WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Birthday HydrationCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company2759f74e-cf64-8bbc-e063-6394a90ace212025-12-18WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Winter MintCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company275ece2b-deb9-c95b-e063-6394a90aa9392025-12-18WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Vanilla CinnamonCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company27722bd0-0a07-53ef-e063-6294a90ae9912025-12-18WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Winter CitrusCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company27723670-70c6-5462-e063-6294a90a84f32025-12-18WarningsExact identifier
application number: M016
Sprayable Diaper Rash CreamZINC OXIDEThe Honest Company, Inc.e0f28717-a87a-2759-e053-2995a90abe7a2025-12-18WarningsExact identifier
application number: M016
Vitamin A DPETROLATUMDynarex Corporationdb4df818-cb0c-434d-e053-2a95a90aaa192025-12-18WarningsExact identifier
application number: M016
Everyday Diaper Rash CreamZINC OXIDEThe Honest Company, Incdfdc5021-9551-3867-e053-2995a90af52b2025-12-16WarningsExact identifier
application number: M016
Aquaphor Healing Fast Relief Diaper RashZINC OXIDEBeiersdorf Inc887e3566-ec5d-4474-83c6-edcc0732f8d62025-12-16WarningsExact identifier
application number: M016
Aquaphor Healing Balm StickPETROLATUMBeiersdorf Incd1670ac6-1672-4b86-e053-2995a90aef602025-12-16Exact identifier
application number: M016
Eucerin Eczema Relief HydrogelOATMEALBeiersdorf Inc15c673fa-739e-a14a-e063-6394a90a30de2025-12-16WarningsExact identifier
application number: M016
EELHOE Supports Healthy Hearing DropsGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.45f838e3-b643-2fdd-e063-6394a90a62f42025-12-15WarningsExact identifier
application number: M016
Crash CreamWHITE PETROLATUMClaridei Laboratories01580e8e-93f3-afeb-e063-6294a90a6cbc2025-12-15WarningsExact identifier
application number: M016
TrueLipids 1% Hydrocortisone Barrier CreamHYDROCORTISONEClaridei Laboratories037395dc-5b96-052e-e063-6394a90a26e42025-12-15WarningsExact identifier
application number: M016
TrueLipids Boo-Boo and Bum Balm CL MDWHITE PETROLATUMClaridei Laboratories, Inc.27bf896e-5614-42f3-e063-6394a90ac3232025-12-15WarningsExact 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