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 39 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Novita Petrolatum Jelly PinkPETROLATUMShield Line LLC3e9d4992-5c1a-16d9-e054-00144ff88e882025-08-18WarningsExact identifier
application number: M016
Novita Pure Petrolatum JellyPETROLATUMShield Line LLC3c55614f-932d-4898-e054-00144ff88e882025-08-18WarningsExact identifier
application number: M016
Arthcal Bioidentical Peach CreamARTHCAL BIOIDENTICAL PEACH CREAMBeijing JUNGE Technology Co., Ltd.3c77f787-b7dd-6813-e063-6394a90aa0042025-08-16Boxed warning, WarningsExact identifier
application number: M016
Natureplex Diaper RashZINC OXIDENatureplex LLC41fe8db3-727c-4bbe-a5ea-62efee4b97b02025-08-15WarningsExact identifier
application number: M016
Aloe Vera Petrolatum JellyPETROLATUMShield Line LLCfdf3b90e-a434-49b2-e053-6394a90ab1752025-08-15WarningsExact identifier
application number: M016
AmeriDerm PeriShieldZINC OXIDEShield Line LLC417f1541-d65a-4612-b96b-e6183fbef1f32025-08-15WarningsExact identifier
application number: M016
AmeriDerm Vitamin A DWHITE PETROLATUMShield Line LLCb73a8fc9-fa00-774a-e053-2995a90afd1e2025-08-15WarningsExact identifier
application number: M016
Baby Petrolatum JellyPETROLATUMSHIELD LINE LLC35c163e6-ae41-2791-e054-00144ff8d46c2025-08-15WarningsExact identifier
application number: M016
MedPride EN SHIELD ALOE SOFT VITAMIN ENRICHEDZINC OXIDEShield Line LLC890ba245-ef37-4c62-ae82-980cb78acfb62025-08-15WarningsExact identifier
application number: M016
Earth Mama Eczema CreamCOLLOIDAL OATMEALEarth Mama Angel Baby, LLCbd30b525-f68c-4786-9fbc-745e2634c6bb2025-08-12WarningsExact identifier
application number: M016
Vitacilina Bebe Diaper RashZINC OXIDETaisho Pharmaceutical California Inc.6701e929-700e-40a4-9117-81e36577bfe12025-08-07WarningsExact identifier
application number: M016
Durma DynaGelDURMA DYNAGELDynarex Corporation3bcbe314-98ca-78f1-e063-6394a90a13ad2025-08-07WarningsExact identifier
application number: M016
Bath Bomb 2-pack (Lemon)ALLANTOINCarolina Cannabis Creations LLC08c7c313-cf36-fb46-e063-6294a90a73042025-08-06WarningsExact identifier
application number: M016
Earthmed Lip Balm Strawberry RhubarbALLANTOINEarthmed LLC3b54eea1-2e09-2ee1-e063-6294a90a52e52025-08-05WarningsExact identifier
application number: M016
ProCure Skin Repair CreamDIMETHICONE 1.5%Twin Med LLC3ba3d3b3-ab13-ea80-e063-6394a90ad4592025-08-05WarningsExact identifier
application number: M016
Earthmed FS Hand and footALLANTOINEarthmed LLC3ba592e9-2ef1-d20a-e063-6394a90a9bae2025-08-05WarningsExact identifier
application number: M016
Earthmed FS massage oilALLANTOINEarthmed LLC3ba64ad2-61b1-8021-e063-6294a90a73352025-08-05WarningsExact identifier
application number: M016
Petroleum JellyBABY PETROLEUM JELLYNeilMed Pharmaceuticals Inc.3b861e02-671a-c9e5-e063-6394a90a8d0f2025-08-04WarningsExact identifier
application number: M016
Earthmed Sport massage oilALLANTOINEarthmed LLC3b92e87d-ba8d-4bac-e063-6294a90a106e2025-08-04WarningsExact identifier
application number: M016
EA EIGHT HOUR SKIN PROTECTANTPETROLATUMREVLONb590991c-8ec8-67c2-e053-2a95a90a3acf2025-08-01WarningsExact 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