Over-the-counter drug · OTC MONOGRAPH DRUG
Balmex Diaper Rash (Zinc oxide 11.3%) NDC 52412-285
Zinc oxide 11.3 g/100g · Cream · Topical · Randob Labs, LTD
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52412-285-02 | 5241202850252412028502 | 1 TUBE in 1 CARTON (52412-285-02) / 56 g in 1 TUBEMarketed from Apr 19, 2021 | |
| 52412-285-03 | 5241202850352412028503 | 1 TUBE in 1 CARTON (52412-285-03) / 85 g in 1 TUBEMarketed from Apr 4, 2023 | |
| 52412-285-04 | 5241202850452412028504 | 1 TUBE in 1 CARTON (52412-285-04) / 113 g in 1 TUBEMarketed from Apr 19, 2021 | |
| 52412-285-12 | 5241202851252412028512 | 340 g in 1 JAR (52412-285-12)Marketed from Apr 19, 2021 | |
| 52412-285-16 | 5241202851652412028516 | 453 g in 1 JAR (52412-285-16)Marketed from Apr 19, 2021 |
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 11.3%
- Active ingredients
- Zinc oxide — 11.3 g/100g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Randob Labs, LTDNDC labeler code 52412
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 016
- Marketing start
- Listing expires
- Identifiers
- Product ID 52412-285_29577ef9-f215-1dc6-e063-6394a90a44abSPL ID 29577ef9-f215-1dc6-e063-6394a90a44abSPL set ID f7f7a89d-d4e0-9faa-e053-6294a90aaf7bRxCUI 630923, 967558UNII SOI2LOH54ZUPC 0030103042003
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
N452412028502followed by a unit qualifier and the quantityPackage 52412-0285-02. 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)
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 52412-285
- What is NDC 52412-285?
- 52412-285 is the product NDC for Balmex Diaper Rash (zinc oxide 11.3%), Zinc oxide 11.3 g/100g cream, listed with the FDA by Randob Labs, LTD. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Balmex Diaper Rash (Zinc Oxide 11.3%).
- 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 | Zinc oxide .113 g/g | CreamTopical | Randob Labs,Ltd. | 52412-400 | 52412-0400-0252412-0400-0452412-0400-05+1 more |
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 |
|---|---|---|---|---|
| Vitamin A Dlanolin, petrolatum | Lanolin 155 mg/g; Petrolatum 534 mg/g | OintmentTopical | Kroger Co. | 30142-022 |
| Scar Treatment Balmallantoin | Allantoin, (R)- .5 g/100g | SalveTopical | Better Planet Brands LLC | 54136-365 |
| BioBarrier Repair Eye Creamallantoin | Allantoin 1.5 g/100g | CreamTopical | Bluemercury Inc. | 72203-020 |
| Boo Boo Magic Diaper Rash Creamyzinc oxide | Zinc oxide 150 mg/mL | SprayTopical | Alboo Brands LLC | 83208-001 |
| Pure petroleumwhite petrolatum | Petrolatum 1 g/g | JellyTopical | Old East Main Co. | 55910-069 |
| ClaraVielanolin | Lanolin 50 g/100g | CreamTopical | Gentell LLC | 61554-307 |
| Aveeno Baby Eczema Therapy Moisturizing Cream Clubtraycolloidal oatmeal | — | KitTopical | Kenvue Brands LLC | 69968-0921 |
| ChapStick Classic Spearmintwhite petrolatum | Petrolatum 450 mg/g | StickTopical | Haleon US Holdings LLC | 0573-0711 |
| Calaminecalamine, pramoxind hcl | Ferric oxide red 80 mg/mL; Pramoxine hydrochloride 10 mg/mL | LotionTopical | Perrigo Direct, Inc | 75981-336 |
| Anubis Barcelonadmae | Glycerin .555 g/30mL + 18 more ingredients | ConcentrateTopical | ANUBIS COSMETICS SL | 83021-546 |
| ODLUMIVIE Dendrobium Restorative Maskdendrobium officinale stem | Dendrobium officinale stem 1 g/100mL | LiquidCutaneous | ODLUMIVIE | 87036-030 |
| OUHOE Lipoma Creamglycerin | Angelica sinensis root .004 mg/20mg; Carthamus tinctorius (Safflower) flower .004 mg/20mg | CreamTopical | Shantou Ouhoe Technology Co., Ltd. | 85163-007 |
| Calaclearpramoxine hydrochloride and zinc acetate | Pramoxine hydrochloride 10 mg/mL; Zinc acetate 1 mg/mL | LotionTopical | Wal-Mart Stores, Inc. | 49035-402 |
| procurepetrolatum | Petrolatum 1 g/g | OintmentTopical | TWIN MED, LLC | 55681-211 |
| insect bite relief 01menthol | Menthol 1 g/100mL | SprayTopical | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 82953-026 |
| Skin protectantpetrolatum | Petrolatum 410 mg/g | OintmentTopical | Nice-Pak Products, LLC | 11344-247 |
| Pure petroleumwhite petrolatum | Petrolatum 1 g/g | JellyTopical | Rite Aid Corporation | 11822-3135 |
| Diaper Rashzinc oxide | Zinc oxide 400 mg/g | PasteTopical | The Kroger Co. | 30142-020 |
| PROCURE VITAMIN A AND D Skin Protectantpetrolatum | Petrolatum 93.4 g/100g | OintmentTopical | TWIN MED, LLC | 55681-215 |
| Aveeno Baby Eczema Therapy Moisturizingoatmeal | Oatmeal 10 mg/mL | CreamTopical | Kenvue Brands LLC | 69968-0923 |
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