Over-the-counter drug · OTC MONOGRAPH FINAL
Balmex Diaper Rash (zinc oxide) NDC 52412-400
Zinc oxide .113 g/g · Cream · Topical · Randob Labs,Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52412-400-02 | 52412040002 | 1 TUBE in 1 CARTON (52412-400-02) / 56 g in 1 TUBEMarketed from Nov 1, 2018 | |
| 52412-400-04 | 52412040004 | 1 TUBE in 1 CARTON (52412-400-04) / 113 g in 1 TUBEMarketed from Nov 1, 2018 | |
| 52412-400-05 | 52412040005 | 5.1 g in 1 PACKAGE (52412-400-05)Marketed from Nov 1, 2018 | |
| 52412-400-16 | 52412040016 | 453 g in 1 JAR (52412-400-16)Marketed from Nov 1, 2018 |
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)
- Balmex Diaper Rash
- Generic name (nonproprietary)
- zinc oxide
- Active ingredients
- Zinc oxide — .113 g/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Randob Labs,Ltd.
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph (final)Application part347
- Marketing start
- Listing expires
- Identifiers
- Product ID 52412-400_18af2fdd-d234-4675-afc6-e0bdd19cdbbdSPL ID 18af2fdd-d234-4675-afc6-e0bdd19cdbbdSPL set ID f202dd0e-7c61-4ea1-a5f6-e90898366ba3RxCUI 630923, 967558UNII SOI2LOH54Z
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
N452412040002followed by a unit qualifier and the quantityPackage 52412-0400-02. 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 diaper rash protects chafed skin due to diaper rash and helps seal out wetness
Excerpt only. Read the full label for complete information.
Other NDCs under part347
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 |
|---|---|---|---|---|
| Natures Choice Vitamins A and Da and d ointment | Petrolatum 99.397 g/100g | OintmentTopical | Unipack, Inc. | 43749-230 |
| Argan Air Water Bang Essencedimethicone | Dimethicone .01 g/100mL | CreamTopical | Pioom Cosmetic Co.,ltd | 70441-0004 |
| Petrolatum | Petrolatum 30 g/100g | CreamTopical | Greenbrier International, Inc. | 33992-0498 |
| Petrolatum | Petrolatum 30 g/100g | CreamTopical | Greenbrier International, Inc. | 33992-0499 |
| TriCalm Hydrogelaluminum acetate | Aluminum acetate 2 mg/mL | GelTopical | Modular Thermal Technologies LLC Dba Life Wear Technologies | 71207-100 |
| Vitamin A and Dlanolin and petrolatum | Lanolin 15.5 g/100g; Petrolatum 53.4 g/100g | OintmentTopical | Family Dollar Services Inc | 55319-103 |
| Oatmeal Skin Relief Calming . 8ozdimethicone | Dimethicone 3 g/227g | LotionTopical | Rejoice International Inc. | 57337-100 |
| Eczema Care Moisturizing 3 oz.colloidal oatmeal | Oatmeal 10 mg/mL | LotionTopical | Rejoice International Inc. | 57337-101 |
| MG217 Baby Eczemacolloidal oatmeal | Oatmeal .02 g/g | LotionTopical | Wisconsin Pharmacal Company | 68093-5105 |
| MG217 Eczema Facecolloidal oatmeal | Oatmeal .02 g/g | LotionTopical | Wisconsin Pharmacal Company | 68093-7245 |
| Balmex Multi-Purposepetrolatum | Petrolatum 511 mg/g | OintmentTopical | Randob Labs,Ltd. | 52412-450 |
| Balmex Adult Care Rashzinc oxide | Zinc oxide .113 g/g | CreamTopical | Randob Labs,Ltd. | 52412-500 |
| CVS Health Diaper Rashzinc oxide | Zinc oxide 400 mg/g | OintmentTopical | CVS Health | 69842-058 |
| Burts Bees Baby Bee Diaper Rashzinc oxide | Zinc oxide 40 g/100g | OintmentTopical | BURT'S BEES, INC. | 26052-028 |
| Astringentcalcium acetate monohydrate and aluminum sulfate tetradecahydrate | Calcium acetate monohydrate 952 mg/2299mg; Aluminum sulfate tetradecahydrate 1347 mg/2299mg | Powder, For solutionTopical | Granulation Technology, Inc. | 63561-0178 |