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 22 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PetroleumWHITE PETROLATUMHarris Teeterde380df6-cc6e-4b2a-98de-fc08eeb6e8ea2026-02-04Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMHy-Vee, Inc.45867f42-9562-c111-e063-6394a90adb702026-02-04Warnings, Adverse reactionsExact identifier
application number: M016
Daily MoisturizingDIMETHICONELidl US, LLCc82f236d-c27f-458c-bcd8-19877d09e9a32026-02-04Warnings, Adverse reactionsExact identifier
application number: M016
Daily MoisturizingDIMETHICONELidl US, LLC5e83811f-773f-43e7-bab8-f9e558fb0e002026-02-04Warnings, Adverse reactionsExact identifier
application number: M016
CalamineFERRIC OXIDE REDMajor Pharmaceuticalsc25be68d-834a-4959-8d47-01ec789406ba2026-02-04Warnings, Adverse reactionsExact identifier
application number: M016
Petroleum Skin ProtectantWHITE PETROLATUMMajor Pharmaceuticals0e7e11c5-a1f8-43c4-b8a6-2114910524042026-02-04Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZELEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)d76e116f-4b22-4633-8487-17ad3b5778c72026-02-04WarningsExact identifier
application number: M016
Comforts Petroleum JellyWHITE PETROLATUMKROGER3feb3638-1cdc-62d4-e063-6294a90a1d892026-02-03WarningsExact identifier
application number: M016
Daily MoisturizingDIMETHICONECVS Pharmacy, Inc.edc20df4-561e-486f-b9f1-900672a0f2a42026-02-03Warnings, Adverse reactionsExact identifier
application number: M016
Colloidal oatmealCOLLOIDAL OATMEALCVS Pharmacy, Inc.a153842c-d9ce-4658-912b-362a6f20b0aa2026-02-03Warnings, Adverse reactionsExact identifier
application number: M016
Petroleum Skin ProtectantWHITE PETROLATUMDemoulas Super Markets, Inc702215f0-4cfd-4a23-b47a-da691c1366342026-02-03Warnings, Adverse reactionsExact identifier
application number: M016
NeurexaCOLLOIDAL OATMEALMETHODIQ INC.494d7915-acad-260e-e063-6394a90a182c2026-02-03WarningsExact identifier
application number: M016
Thera Plus Vitamin A and D CreamDIMETHICONE, ZINC OXIDEFOURSTAR GROUP USA, INC.36f09fa4-a3b8-4104-9745-ee60aa493b062026-02-02WarningsExact identifier
application number: M016
Vitamin A DLANOLIN, PETROLATUMKroger Co.b4aa9b58-d95e-4dac-9a34-213482e8ca342026-02-02Warnings, Adverse reactionsExact identifier
application number: M016
Nail Nourishing PenGLYCERINShantou Ximonth Biotechnology Co., Ltd.49e45462-a05f-d370-e063-6394a90a1e0f2026-02-02WarningsExact identifier
application number: M016
Barrier Repair CreamCREAMSteel City Health Private Limited4842f653-7137-eca4-e063-6394a90a8c552026-01-31WarningsExact identifier
application number: M016
Cracked Heel Repair BalmDIMETHICONEDelta Brands Inc.42b7c9f8-0557-8e33-e063-6394a90a59192026-01-30WarningsExact identifier
application number: M016
Readybath TPC Total Perineal CareDIMETHICONEMedline Industries, Inc.43a3f0f7-f76f-434d-a21f-7eaa3638913d2026-01-30WarningsExact identifier
application number: M016
Lanolin, PetrolatumLANOLIN, PETROLATUMRite Aid Corporation1b6d7cdf-e7bc-4fd4-939c-5eb0eaa1744d2026-01-30Warnings, Adverse reactionsExact identifier
application number: M016
Zinc OxideZINC OXIDERite Aid Corporation3af9f0e5-0d79-4178-b29e-3b60735bf4ce2026-01-30Warnings, Adverse reactionsExact 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