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 | 5241204000252412040002 | 1 TUBE in 1 CARTON (52412-400-02) / 56 g in 1 TUBEMarketed from Nov 1, 2018 | |
| 52412-400-04 | 5241204000452412040004 | 1 TUBE in 1 CARTON (52412-400-04) / 113 g in 1 TUBEMarketed from Nov 1, 2018 | |
| 52412-400-05 | 5241204000552412040005 | 5.1 g in 1 PACKAGE (52412-400-05)Marketed from Nov 1, 2018 | |
| 52412-400-16 | 5241204001652412040016 | 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.NDC labeler code 52412
- 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.
About NDC 52412-400
- What is NDC 52412-400?
- 52412-400 is the product NDC for Balmex Diaper Rash (zinc oxide), Zinc oxide .113 g/g cream, listed with the FDA by Randob Labs,Ltd.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Balmex Diaper Rash (Zinc Oxide).
- What is the active ingredient?
- Zinc oxide.
- Who is the labeler?
- Randob Labs,Ltd., NDC labeler code 52412. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Balmex Diaper Rash?
- 1 other product NDC are listed under this name. See all Balmex Diaper Rash NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Balmex Diaper Rash products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Balmex Diaper Rashzinc oxide 11.3% | Zinc oxide 11.3 g/100g | CreamTopical | Randob Labs, LTD | 52412-285 | 52412-0285-0252412-0285-0352412-0285-04+2 more |
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 |
|---|---|---|---|---|
| Oatmeal Skin Relief Calming . 8ozdimethicone | Dimethicone 3 g/227g | LotionTopical | Rejoice International Inc. | 57337-100 |
| CVS Health Diaper Rashzinc oxide | Zinc oxide 400 mg/g | OintmentTopical | CVS Health | 69842-058 |
| TriCalm Hydrogelaluminum acetate | Aluminum acetate 2 mg/mL | GelTopical | Modular Thermal Technologies LLC Dba Life Wear Technologies | 71207-100 |
| Eczema Care Moisturizing 3 oz.colloidal oatmeal | Oatmeal 10 mg/mL | LotionTopical | Rejoice International Inc. | 57337-101 |
| Vitamin A and Dlanolin and petrolatum | Lanolin 15.5 g/100g; Petrolatum 53.4 g/100g | OintmentTopical | Family Dollar Services Inc | 55319-103 |
| Balmex Adult Care Rashzinc oxide | Zinc oxide .113 g/g | CreamTopical | Randob Labs,Ltd. | 52412-500 |
| 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 |
| Natures Choice Vitamins A and Da and d ointment | Petrolatum 99.397 g/100g | OintmentTopical | Unipack, Inc. | 43749-230 |
| 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 |
| Petrolatum | Petrolatum 30 g/100g | CreamTopical | Greenbrier International, Inc. | 33992-0498 |
| Petrolatum | Petrolatum 30 g/100g | CreamTopical | Greenbrier International, Inc. | 33992-0499 |
| Balmex Multi-Purposepetrolatum | Petrolatum 511 mg/g | OintmentTopical | Randob Labs,Ltd. | 52412-450 |
| Argan Air Water Bang Essencedimethicone | Dimethicone .01 g/100mL | CreamTopical | Pioom Cosmetic Co.,ltd | 70441-0004 |
| Burts Bees Baby Bee Diaper Rashzinc oxide | Zinc oxide 40 g/100g | OintmentTopical | BURT'S BEES, INC. | 26052-028 |