AD Skin Protectant
- Product NDC
- 65197-470
- 11-digit product format
- 651970470
- Labeler code
- 65197
- Product ID
- 65197-470_45ffedac-d2b6-4783-9c15-ff538ce73a7e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- AD Skin Protectant
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- WellSpring Pharmaceutical Corporation
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-01-20
- Substance
- LANOLIN; PETROLATUM
- Active strength
- 15.5; 53.4 g/100g; g/100g
- 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
- AD Skin Protectant
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LANOLIN | 15.5 g/100g |
| PETROLATUM | 53.4 g/100g |
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 |
|---|---|
| d26f1312-2e1b-4106-bc48-a336d4e034ad | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65197-470-16 | AD Skin Protectant | 454 g in 1 JAR | OINTMENT | 454 | 5 | |
| 65197-470-35 | AD Skin Protectant | 99 g in 1 TUBE | OINTMENT | 99 | 5 | |
| 65197-470-35 | AD Skin Protectant | 1 in 1 BOX | OINTMENT | 1 | 5 |
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 |
|---|---|---|---|---|---|---|
| EltaMD Laser Balm | PETROLATUM SKIN PROTECTANT | CP Skin Health Group, Inc | 1c67ce72-89d9-4c4f-a9b0-28b7e67d30eb | 2023-11-09 | Warnings | M016 |
| DiaperDerm Diaper Rash | ZINC OXIDE | Diaperderm Inc | 4e1fce3e-c2b7-42da-9953-1dbb13e2467c | 2023-11-06 | Warnings | M016 |
| Doctors Diaper Rash Cream | ZINC OXIDE | DOCTOR'S DIAPER RASH CREAM, INC | 0988ccb1-7881-4d97-bcbf-d0cf4316e4be | 2023-11-06 | Warnings | M016 |
| DERMOIA Manuka Honey Eczema Cream | OATMEAL | TREASUREWISE LLC | a48e52a3-b681-4489-a1fd-6b09d8bc9c55 | 2023-11-06 | Warnings | M016 |
| GL HEALTH Barrier Skin Protectant | ZINC OXIDE | GL HEALTH, INC. | 76cfa330-fea9-48d4-b187-469154765d39 | 2023-11-06 | Warnings | M016 |
| Skin-lube | PETROLATUM, DIMETHICONE | The Hygenic Company, LLC. | d1005dec-04f6-3f88-e053-2a95a90ad9cb | 2023-11-05 | Warnings | M016 |
| Dr. Sheffield Anti Itch Cream | ANTI ITCH CREAM | Sheffield Pharmaceuticals LLC | 77f0593e-f694-4c02-9fd9-ad56ff2a920c | 2023-10-30 | Warnings | M016 |
| calahist | CALAMINE AND PRAMOXINE HYDROCHLORIDE | WALGREEN COMPANY | fed45e06-cc53-fbc5-e053-6294a90a1b19 | 2023-10-27 | Warnings | M016 |
| calahist clear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE | WALGREEN COMPANY | fed469c2-fe13-6726-e053-6394a90a5f51 | 2023-10-27 | Warnings | M016 |
| Dr. Sayman Salve | SALVE | Sheffield Pharmaceuticals LLC | 18bdcd0c-9c81-47e1-ae24-2239ff8fd066 | 2023-10-24 | Warnings | M016 |
| Theriac Advanced Healing | LANOLIN | Sheffield Pharmaceuticals LLC | c780cd27-dc9e-45f3-97f0-e59b1b6b955a | 2023-10-24 | Warnings | M016 |
| Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash | ZINC OXIDE | Babo Botanicals, Inc. | d66e369e-9b19-b084-e053-2995a90aa259 | 2023-10-23 | Warnings | M016 |
| Babo Botanicals Sensitive Baby Healing | COLLOIDAL OATMEAL | Babo Botanicals, Inc. | 08659a5c-2d10-2f98-e063-6394a90a7760 | 2023-10-23 | Warnings | M016 |
| White Rose Petroleum Jelly | PETROLATUM | J. Strickland & Co. | 1aeb090d-c103-4c2e-accc-d9d248315db9 | 2023-10-21 | Warnings | M016 |
| Tricalm Hydrogel | ALUMINUM ACETATE | MODULAR THERMAL TECHNOLOGIES LLC DBA LIFE WEAR TECHNOLOGIES | 082c6441-be47-4466-e063-6394a90ad500 | 2023-10-20 | Warnings | M016 |
| Empower | WHITE PETROLATUM, ZINC OXIDE | Bemis Manufacturing Company Inc | 08006b60-966b-155b-e063-6294a90a206a | 2023-10-18 | Warnings | M016 |
| ANUBISMED | HA HYALURONIC | ANUBIS COSMETICS SL | eac771e2-4c1b-3808-e053-2995a90ac5fc | 2023-09-05 | Warnings | M016 |
| AnubisMed | SODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, IMIDAZOLIDINYL UREA | ANUBIS COSMETICS SL | ebf4b3ab-34e1-185a-e053-2a95a90ace3a | 2023-09-05 | Warnings | M016 |
| Anubis Barcelona | GLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICE | ANUBIS COSMETICS SL | eb651769-4d98-2b3b-e053-2a95a90a36b0 | 2023-09-01 | Warnings | M016 |
| Anubis Barcelona | DMAE | ANUBIS COSMETICS SL | f22b212d-d21d-5984-e053-2995a90a683e | 2023-09-01 | Warnings | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 664981 | lanolin 15.5 % / petrolatum 53.4 % Topical Ointment | PSN | d26f1312-2e1b-4106-bc48-a336d4e034ad | 5 |
| 664981 | lanolin 0.155 MG/MG / petrolatum 0.534 MG/MG Topical Ointment | SCD | d26f1312-2e1b-4106-bc48-a336d4e034ad | 5 |
| 664981 | lanolin 15.5 % / petrolatum 53.4 % Topical Ointment | SY | d26f1312-2e1b-4106-bc48-a336d4e034ad | 5 |
| 664981 | lanolin 15.5 GM per 100 GM / petrolatum 53.4 GM per 100 GM Topical Ointment | SY | d26f1312-2e1b-4106-bc48-a336d4e034ad | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 65197-470-16 | 65197047016 | 454 g in 1 JAR (65197-470-16) | 454 g | 2025-03-15 | No | No | Current |
| 65197-470-35 | 65197047035 | 1 TUBE in 1 BOX (65197-470-35) / 99 g in 1 TUBE | 1 tube | 2025-01-20 | No | No | Current |