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 |
|---|---|
| LANOLIN | 155 mg/g |
| PETROLATUM | 534 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 7EV65EAW6H | Internal UNII lookup |
| 4T6H12BN9U | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 664981 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 448b70db-ca81-db7b-e063-6294a90a5f0d | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 13709-352-01 | Skin Protectant for Babies and kids | 1 in 1 CARTON | OINTMENT | 1 | 1 | |
| 13709-352-01 | Skin Protectant for Babies and kids | 113 g in 1 TUBE | OINTMENT | 113 | 1 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Hydro Gel | GLYCERIN 20% | Trifecta Pharmaceuticals USA LLC | 02e8e5d0-7844-39fe-e063-6394a90a57e1 | 2024-01-19 | Warnings | M016 |
| White Petrolatum | WHITE PETROLATUM | Sled Distribution, LLC | e73a4b7a-7b27-abfc-e053-2995a90a35c2 | 2024-01-15 | Warnings | M016 |
| Sunmark Caldiphen | CALAMINE AND PRAMOXINE HYDROCHLORIDE | Strategic Sourcing Services | 4f4d4c54-64b5-4e20-bed0-c7fb470b8434 | 2024-01-12 | Warnings | M016 |
| EIGHT HOUR NIGHT | DIMETHICONE | REVLON | b3b277f9-565a-636c-e053-2995a90a94d2 | 2024-01-12 | Warnings | M016 |
| CeraVe Developed with Dermatologists Eczema Relief Creamy | OATMEAL | L'Oreal USA Products Inc | bcf7b985-6875-4033-a412-1bb6d3afa6d8 | 2024-01-01 | Warnings | M016 |
| CeraVe Developed with Dermatologists Healing | PETROLATUM | L'Oreal USA Products Inc. | 1b3ad3e8-cbac-4a92-84e2-4f3ab4512d95 | 2023-12-31 | Warnings | M016 |
| CeraVe Developed with Dermatologists Baby Healing | PETROLATUM | L'Oreal USA Products Inc. | fe665bbc-1172-4f59-acc6-8d5c179693b6 | 2023-12-31 | Warnings | M016 |
| Quality Choice Anti-Itch Clear | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | Chain Drug Market Association | e3c0c46d-3d85-411d-a543-009064cdd19e | 2023-12-28 | Warnings | M016 |
| CeraVe Developed with Dermatologists Therapeutic Hand | DIMETHICONE | L'Oreal USA Products Inc | 7fe49112-4180-415c-a380-768a8d6b2185 | 2023-12-28 | Warnings | M016 |
| Calaclear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE | Pharma Nobis, LLC | e42fccc2-1b4e-e7f3-e053-2a95a90aef39 | 2023-12-26 | Warnings | M016 |
| Calamine Phenolated Topical Suspension | CALAMINE AND ZINC OXIDE AND PHENOL | Pharma Nobis, LLC | e42fbdcc-3291-7761-e053-2995a90a7172 | 2023-12-26 | Warnings | M016 |
| Humco Calagesic | CALAMINE AND PRAMOXINE HYDROCHLORIDE | Pharma Nobis, LLC | e42fb807-8cb4-ed25-e053-2995a90a6780 | 2023-12-26 | Warnings | M016 |
| Leader Calamine Plus | ZINC OXIDE LOTION | Cardinal Health, 110 dba Leader | 81f29789-f794-1e64-e053-2a91aa0ac85e | 2023-12-22 | Warnings | M016 |
| CVS Calamine Plus | ZINC OXIDE | CVS Pharmacy | b90cd214-d44a-4458-876d-59cc0795226d | 2023-12-22 | Warnings | M016 |
| Calamine | CALAMINE 8% AND ZINC OXIDE 8% | Pharma Nobis, LLC | e42f0bd6-3ad3-7e07-e053-2995a90a564a | 2023-12-22 | Warnings | M016 |
| DDM Calamine | CALAMINE 8% AND ZINC OXIDE 8% | Discount Drug Mart | 5d53685b-ca4c-35c1-e053-2a91aa0aff6e | 2023-12-20 | Warnings | M016 |
| DDM Calagesic | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | Discount Drug Mart | 5d537a11-049e-0a8d-e053-2a91aa0aa0c3 | 2023-12-20 | Warnings | M016 |
| Health Mart Calamine | CALAMINE 8% AND ZINC OXIDE 8% | Strategic Sourcing Services LLC | 349ea07d-79bc-46f3-9d60-85b40db51bbb | 2023-12-20 | Warnings | M016 |
| Health Mart Witch Hazel | WITCH HAZEL | Strategic Sourcing Services LLC | 2a1d9b27-0bd4-4475-8218-ba0f5560a969 | 2023-12-20 | Warnings | M016 |
| Quality Choice Calamine | CALAMINE 8% AND ZINC OXIDE 8% | Chain Drug Market Association | 62fe653f-e861-472b-b193-4fdd9d25de8d | 2023-12-20 | Warnings | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 664981 | lanolin 15.5 % / petrolatum 53.4 % Topical Ointment | PSN | 448b70db-ca81-db7b-e063-6294a90a5f0d | 1 |
| 664981 | lanolin 0.155 MG/MG / petrolatum 0.534 MG/MG Topical Ointment | SCD | 448b70db-ca81-db7b-e063-6294a90a5f0d | 1 |
| 664981 | lanolin 15.5 % / petrolatum 53.4 % Topical Ointment | SY | 448b70db-ca81-db7b-e063-6294a90a5f0d | 1 |
| 664981 | lanolin 15.5 GM per 100 GM / petrolatum 53.4 GM per 100 GM Topical Ointment | SY | 448b70db-ca81-db7b-e063-6294a90a5f0d | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 13709-352-01 | 13709035201 | 1 TUBE in 1 CARTON (13709-352-01) / 113 g in 1 TUBE | 1 tube | 2026-01-02 | No | No | Current |