Calamine
- Product NDC
- 82645-418
- 11-digit product format
- 826450418
- Labeler code
- 82645
- Product ID
- 82645-418_52b97551-89e2-c3b8-e063-6394a90af476
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Calamine and Zinc Oxide
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Pharma Nobis, LLC
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-05-16
- Substance
- FERRIC OXIDE RED; ZINC OXIDE
- Active strength
- 80; 80 mg/mL; mg/mL
- Pharmacologic classes
- Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Calamine
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FERRIC OXIDE RED | 80 mg/mL |
| ZINC OXIDE | 80 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1K09F3G675 | Internal UNII lookup |
| SOI2LOH54Z | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 617954 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| fbcfa541-beda-06de-e053-6294a90a9298 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82645-418-96 | Calamine | 177 mL in 1 BOTTLE, PLASTIC | LOTION | 177 | 3 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Witch Hazel | WITCH HAZEL | Meijer Distribution Inc | 03f23b04-e7f7-49b7-e063-6294a90ad58a | 2025-10-31 | Warnings | M016 |
| Diaper Rash skin protectant | LANOLIN AND PETROLATUM | Universal Distribution Centre LLC | 1852246a-6a1c-49ab-e063-6294a90a9048 | 2025-10-30 | Warnings | M016 |
| FB HYDRATING HAND SANITIZER | FB HYDRATING HAND SANITIZER | FAMILY DOLLAR SERVICES, LLC | 20b531c1-9ab0-5ff1-e063-6394a90a2975 | 2025-10-30 | Warnings | M016 |
| FB HYDRATING HAND SANITIZER | FB HYDRATING HAND SANITIZER | FAMILY DOLLAR SERVICES, LLC | 20b650bd-18fe-8696-e063-6394a90aa9a2 | 2025-10-30 | Warnings | M016 |
| FB HYDRATING HAND SANITIZER | FB HYDRATING HAND SANITIZER | FAMILY DOLLAR SERVICES, LLC | 20b5f354-3379-3d9f-e063-6294a90ae817 | 2025-10-30 | Warnings | M016 |
| Boudreauxs | ZINC OXIDE | C.B. Fleet Company, Inc. | 59d90652-a471-4f77-a3d5-88aad9dc9e13 | 2025-10-30 | Warnings | M016 |
| CVS Cools Itch Fast | HYDROCORTISONE | CVS Pharmacy, Inc. | 8a4544df-bbba-47d2-ada0-352757abc91f | 2025-10-29 | Warnings | M016 |
| Winco Maximum Strength Hydrocortisone | HYDROCORTISONE | WINCO FOODS, LLC | b1812ea3-78cc-607a-e053-2a95a90a0a10 | 2025-10-29 | Warnings | M016 |
| Good Neighbor Pharmacy Skin Protectant | ZINC OXIDE | AMERISOURCE BERGEN | c28e63f1-34be-9206-e053-2995a90accf6 | 2025-10-29 | Warnings | M016 |
| Remedy Nutrashield | DIMETHICONE | Medline Industries, LP | ed8a08a7-594c-46e2-b70f-b75b2960141f | 2025-10-28 | Warnings | M016 |
| American Red Cross Anti-Itch | HYDROCORTISONE 1.0%(W/W) | MY IMPORTS USA LLC | 421da126-a1c4-54d7-e063-6394a90ac401 | 2025-10-27 | Warnings | M016 |
| GeriGard | ZINC OXIDE | Geri-Gentle Corporation | 05b67830-adc8-46b1-b0a0-a6cd2875e80c | 2025-10-27 | Warnings | M016 |
| Boudreauxs Butt Barrier | DIMETHICONE | C.B. Fleet Company, Inc. | 06a5af4d-40dd-42a4-8368-4d6a772d1b3a | 2025-10-27 | Warnings | M016 |
| Boudreauxs Baby Shower Bundle | ZINC OXIDE | C.B. Fleet Company, Inc. | a289ed3c-3c7a-4eda-bf5e-139203d2e17e | 2025-10-27 | Warnings | M016 |
| WinCo Original Strength Anti-Itch | DIPHENHYDRAMINE HYDROCHLORIDE, AND ZINC ACETATE | WinCo Foods, LLC | ae74e163-ba1a-4d1e-aaeb-9976bd202674 | 2025-10-24 | Warnings | M016 |
| Maximum Strength Moisture Barrier | PETROLATUM AND ZINC OXIDE | Derma Sciences Canada Inc. | 41ee91c0-d196-cc0f-e063-6394a90a7b97 | 2025-10-24 | Warnings | M016 |
| Tenderphor | SKIN PROTECTANT | GERI-GENTLE CORPORATION | e6763da3-cbd1-7a86-e053-2995a90a26c1 | 2025-10-23 | Warnings | M016 |
| Boudreauxs | ZINC OXIDE | C.B. Fleet Company, Inc. | 262278f6-7e4c-44ee-b40d-39662a239d73 | 2025-10-23 | Warnings | M016 |
| American Red Cross Anti-Itch | HYDROCORTISONE 1.0%(W/W) | Zhejiang Guoyao Jingyue Aerosol Co., Ltd. | 41b8cb00-a04e-52f0-e063-6294a90aabf7 | 2025-10-22 | Warnings | M016 |
| WinCo Foods Hydrocortisone Cream Intensive Healing | HYDROCORTISONE | WINCO FOODS, LLC | ac4e0e24-9295-b83b-e053-2995a90a996f | 2025-10-22 | Warnings | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 617954 | calamine 8 % / zinc oxide 8 % Topical Lotion | PSN | fbcfa541-beda-06de-e053-6294a90a9298 | 3 |
| 617954 | calamine 80 MG/ML / zinc oxide 80 MG/ML Topical Lotion | SCD | fbcfa541-beda-06de-e053-6294a90a9298 | 3 |
| 617954 | calamine 8 % / zinc oxide 8 % Topical Lotion | SY | fbcfa541-beda-06de-e053-6294a90a9298 | 3 |
| 617954 | Calamine 80 MG/ML / ZNO 80 MG/ML Topical Lotion | SY | fbcfa541-beda-06de-e053-6294a90a9298 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 82645-418-96 | 82645041896 | 177 mL in 1 BOTTLE, PLASTIC (82645-418-96) | 177 ml | 2023-05-16 | No | No | Current |