Over-the-counter drug · OTC MONOGRAPH DRUG
Astringent NDC 63561-0178
calcium acetate monohydrate and aluminum sulfate tetradecahydrate · Calcium acetate monohydrate 952 mg/2299mg; Aluminum sulfate tetradecahydrate 1347 mg/2299mg · Powder, For solution · Topical · Granulation Technology, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63561-0178-2 | 6356101780263561017802 | 12 PACKET in 1 CARTON (63561-0178-2) / 2299 mg in 1 PACKET (63561-0178-1)Marketed from Jun 12, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Astringent
- Generic name (nonproprietary)
- calcium acetate monohydrate and aluminum sulfate tetradecahydrate
- Active ingredients
- Calcium acetate monohydrate — 952 mg/2299mgAluminum sulfate tetradecahydrate — 1347 mg/2299mg
- Dosage form
- Powder, For solution
- Route
- Topical
- Labeler
- Granulation Technology, Inc.NDC labeler code 63561
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication part347
- Marketing start
- Listing expires
- Other FDA classes
- Calcium (Chemical structure)Divalent (Chemical structure)Increased Coagulation Factor Activity (Physiologic effect)Phosphate Chelating Activity (Mechanism)
- Identifiers
- Product ID 63561-0178_37553cf5-a897-fef9-e063-6394a90a7812SPL ID 37553cf5-a897-fef9-e063-6394a90a7812SPL set ID 1c2bf19c-2f32-4a22-a371-16cc744dce76RxCUI 1250234UNII 7ZA48GIM5H, E3UT66504PUPC 0363561017826
- Pharmacologic class
- Blood Coagulation Factor; Phosphate Binder
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
N463561017802followed by a unit qualifier and the quantityPackage 63561-0178-02. 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 Temporarily relieves minor skin irritations due to: Poison ivy Poison oak Poison sumac Insect bites Athlete's foot Rashes caused by soaps, detergents, cosmetics, or jewelry
Excerpt only. Read the full label for complete information.
About NDC 63561-0178
- What is NDC 63561-0178?
- 63561-0178 is the product NDC for Astringent, Calcium acetate monohydrate 952 mg/2299mg; Aluminum sulfate tetradecahydrate 1347 mg/2299mg powder, for solution, listed with the FDA by Granulation Technology, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Astringent (Calcium acetate monohydrate and Aluminum sulfate tetradecahydrate).
- What is the active ingredient?
- Calcium acetate monohydrate, Aluminum sulfate tetradecahydrate.
- Who is the labeler?
- Granulation Technology, Inc., NDC labeler code 63561. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Astringent?
- 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 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 |
| 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 |
| Balmex Diaper Rashzinc oxide | Zinc oxide .113 g/g | CreamTopical | Randob Labs,Ltd. | 52412-400 |
| 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 |