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NDC 36800-0336-30 Calamine 80; 10 mg/mL; mg/mL Details
Calamine 80; 10 mg/mL; mg/mL
Calamine is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Topco associates LLC. The primary component is FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE.
Product Information
| NDC | 36800-0336 |
|---|---|
| Product ID | 36800-336_4f9fa34d-9a25-42be-a68a-bb1055b773b0 |
| Associated GPIs | 90859902934120 |
| GCN Sequence Number | 022061 |
| GCN Sequence Number Description | pramoxine HCl/calamine LOTION 1 %-8 % TOPICAL |
| HIC3 | L3P |
| HIC3 Description | ANTIPRURITICS,TOPICAL |
| GCN | 65328 |
| HICL Sequence Number | 010079 |
| HICL Sequence Number Description | PRAMOXINE HCL/CALAMINE |
| Brand/Generic | Generic |
| Proprietary Name | Calamine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Calamine, Pramoxind HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LOTION |
| Route | TOPICAL |
| Active Ingredient Strength | 80; 10 |
| Active Ingredient Units | mg/mL; mg/mL |
| Substance Name | FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE |
| Labeler Name | Topco associates LLC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part347 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 36800-0336-30 (36800033630)
| NDC Package Code | 36800-336-30 |
|---|---|
| Billing NDC | 36800033630 |
| Package | 177 mL in 1 BOTTLE, PLASTIC (36800-336-30) |
| Marketing Start Date | 2009-05-21 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |