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NDC 00187-5465-06 Caladryl 1.36; 10; 78.65 mg/mL; mg/mL; mg/mL Details
Caladryl 1.36; 10; 78.65 mg/mL; mg/mL; mg/mL
Caladryl is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Bausch Health US, LLC. The primary component is FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE; ZINC OXIDE.
Product Information
| NDC | 00187-5465 |
|---|---|
| Product ID | 0187-5465_c2b35f23-4193-4877-a079-1405d88246b6 |
| 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 | Brand |
| Proprietary Name | Caladryl |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Ferric Oxide Red, Zinc Oxide, and Pramoxine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LOTION |
| Route | TOPICAL |
| Active Ingredient Strength | 1.36; 10; 78.65 |
| Active Ingredient Units | mg/mL; mg/mL; mg/mL |
| Substance Name | FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE; ZINC OXIDE |
| Labeler Name | Bausch Health US, 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 00187-5465-06 (00187546506)
| NDC Package Code | 0187-5465-06 |
|---|---|
| Billing NDC | 00187546506 |
| Package | 177 mL in 1 BOTTLE, PLASTIC (0187-5465-06) |
| Marketing Start Date | 2013-08-16 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |