Over-the-counter drug · OTC MONOGRAPH DRUG
AD Skin Protectant NDC 65197-470
Lanolin 15.5 g/100g; Petrolatum 53.4 g/100g · Ointment · Topical · WellSpring Pharmaceutical Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65197-470-16 | 65197047016 | 454 g in 1 JAR (65197-470-16)Marketed from Mar 15, 2025 | |
| 65197-470-35 | 65197047035 | 1 TUBE in 1 BOX (65197-470-35) / 99 g in 1 TUBEMarketed from Jan 20, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- AD Skin Protectant
- Generic name (nonproprietary)
- ad skin protectant
- Active ingredients
- Lanolin — 15.5 g/100gPetrolatum — 53.4 g/100g
- Dosage form
- Ointment
- Route
- Topical
- Labeler
- WellSpring Pharmaceutical CorporationNDC labeler code 65197
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 016
- Marketing start
- Listing expires
- Identifiers
- Product ID 65197-470_45ffedac-d2b6-4783-9c15-ff538ce73a7eSPL ID 45ffedac-d2b6-4783-9c15-ff538ce73a7eSPL set ID d26f1312-2e1b-4106-bc48-a336d4e034adRxCUI 664981UNII 7EV65EAW6H, 4T6H12BN9U
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N465197047016followed by a unit qualifier and the quantityPackage 65197-0470-16. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses helps treat and prevent incontinence rash protects chafed skin associated with incontinence rash and helps seal out wetness temporarily protects and helps relieve chapped or cracked skin and lips
Excerpt only. Read the full label for complete information.
About NDC 65197-470
- What is NDC 65197-470?
- 65197-470 is the product NDC for AD Skin Protectant, Lanolin 15.5 g/100g; Petrolatum 53.4 g/100g ointment, listed with the FDA by WellSpring Pharmaceutical Corporation. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- AD Skin Protectant.
- What is the active ingredient?
- Lanolin, Petrolatum.
- Who is the labeler?
- WellSpring Pharmaceutical Corporation, NDC labeler code 65197. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for AD Skin Protectant?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under M 016
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Bath Bomb 6-pack (Lavender)allantoin | Allantoin 3.1 g/555.3g; Sodium bicarbonate 248 g/555.3g | Tablet, SolubleTopical | Carolina Cannabis Creations LLC | 82876-508 |
| Nail Nourishing Penglycerin | Borneol .012 mg/12mg; Tea tree oil .0024 mg/12mg | LiquidTopical | Shantou Ximonth Biotechnology Co., Ltd. | 84989-018 |
| Softlips Cherry, Raspberry, Vanilladimethicone | Dimethicone 20 mg/g | StickTopical | The Mentholatum Company | 10742-7002 |
| Foaming Facial Cleanserglycerin, niacinamide | Glycerin 40 mg/mL; Niacinamide 5 mg/mL | CreamTopical | Guangzhou Danting Bath&Body Care Industry Co. Ltd | 75376-103 |
| Secura Protectivepetrolatum | Petrolatum 988.49 mg/g | OintmentTopical | Smith & Nephew Medical Ltd | 69740-316 |
| Dermaka Infants and Kids Multi Purpose Skin Protectantzinc oxide | Zinc oxide 250 mg/mL | OintmentTopical | Dermaka Skin Products LLC | 82240-014 |
| Bath Bomb 2-pack (Peppermint)allantoin | Allantoin 1.1 g/186.16g; Sodium bicarbonate 82 g/186.16g | Tablet, SolubleTopical | Carolina Cannabis Creations LLC | 82876-505 |
| XIMONTH Nail Repairs Patchesglycerin | Aloe barbadensis leaf .012 mg/60mg; Sophora flavescens root .012 mg/60mg | PatchTopical | Shantou Ximonth Biotechnology Co., Ltd. | 84989-015 |
| Major Medi-Padswitch hazel | Witch hazel 50 g/100g | ClothTopical | Major Pharmaceuticals | 0904-6829 |
| terrasil Foreskin Reliefallantoin | Allantoin .5 g/100g | OintmentTopical | Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions | 24909-058 |
| Petroleum Skin Protectantwhite petrolatum | Petrolatum 1 g/g | JellyTopical | Meijer, Inc. | 41250-069 |
| Rugby Zinc Oxide 20% | Zinc oxide 20 g/100g | OintmentTopical | Rugby Laboratories | 0536-1316 |
| Drs. DIAPER RASH MAXIMUM STRENGTHzinc oxide | Zinc oxide 10 g/100g; Dimethicone 1 g/100g | CreamTopical | OL PHARMA TECH, LLC Drs PHARMACY | 80489-576 |
| Bath Bomb 2-pack (Eucalyptus)allantoin | Allantoin 1.1 g/186.16g; Sodium bicarbonate 82 g/186.16g | Tablet, SolubleTopical | Carolina Cannabis Creations LLC | 82876-506 |
| Nail Repairs Patchesglycerin | Aloe barbadensis leaf .012 mg/60mg; Sophora flavescens root .012 mg/60mg | PatchTopical | Shantou Ximonth Biotechnology Co., Ltd. | 84989-016 |
| Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15camphor (synthetic), white petrolatum, octinoxate, oxybenzone | — | Kit | Carma Laboratories, Inc. | 10210-0060 |
| Daily Moisturizingdimethicone | Dimethicone 1.3 kg/100mL | LotionTopical | CVS Pharmacy, Inc. | 69842-771 |
| Bath Bomb 6-pack (Lemon)allantoin | Allantoin 3.1 g/560.55g; Sodium bicarbonate 248 g/560.55g | Tablet, SolubleTopical | Carolina Cannabis Creations LLC | 82876-507 |
| XIMONTH Nail Nourishing Penglycerin | Tea tree oil .0024 mg/12mg | LiquidTopical | Shantou Ximonth Biotechnology Co., Ltd. | 84989-017 |
| White Rose Petroleum Jellypetrolatum | Petrolatum 1000 mg/g | OintmentTopical | J. Strickland & Co. | 12022-031 |
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