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 |
|---|---|---|---|---|---|---|
| SUPRADERM | WHITE PETROLATUM, LANOLIN | Olen Skin Care Corporation | 4e7199bd-52c6-48e9-9c78-c84e45412faf | 2026-06-10 | Warnings | M016 |
| Medline | DIMETHICONE | Medline Industries, LP | 509ee758-9d53-220c-e063-6394a90a4bd5 | 2026-06-09 | Warnings | M016 |
| BABY BUM DIAPER | ZINC OXIDE | Creative Consumer Products, Inc. DBA (Doing Business As) Dionis Goat Milk Skincare | 53d8a654-aaec-6f91-e063-6394a90a7351 | 2026-06-09 | Warnings | M016 |
| CELISTAR MICRONEEDLING INFUSION | HYALURONATE SODIUM | Guangdong Outeli Biotechnology Co., Ltd. | 53de46a7-3947-70a7-e063-6294a90ab829 | 2026-06-09 | Warnings | M016 |
| Medline | DIMETHICONE | Medline Industries, LP | 3c448cf7-8ca5-c7f7-e063-6294a90a75ff | 2026-06-08 | Warnings | M016 |
| WOODSLEEP Wild Yam Cream | GLYCERIN | Shantou Woodsleep Biotechnology Co., Ltd. | 53b992fd-5759-57bb-e063-6394a90a1600 | 2026-06-08 | Warnings | M016 |
| XIMONTH Fungi Free Bee Venom Nail Soothing Serum | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 53bab969-8407-6334-e063-6294a90aa5d1 | 2026-06-08 | Warnings | M016 |
| GNP Calamine Topical Suspension | CALAMINE 8% AND ZINC OXIDE 8% | Amerisource Bergen | 777b0e66-1bce-4483-9dad-c46796fd6f23 | 2026-06-04 | Warnings | M016 |
| GNP Caldyphen | CALAMINE AND PRAMOXINE HYDROCHLORIDE | Amerisource Bergen | 515c58d7-0dc4-45e7-9155-e5270a16290e | 2026-06-04 | Warnings | M016 |
| First Aid Beauty Sensitive Skin Bestsellers Kit | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | 535a0e8e-6bb4-6652-e063-6394a90aa7ff | 2026-06-03 | Warnings | M016 |
| Quad Wash | DIMETHICONE | Dynarex Corporation | 535dc862-6a18-26c9-e063-6294a90a3d4a | 2026-06-03 | Warnings | M016 |
| First Aid Beauty Sensitive Skin Bestsellers Kit | COLLOIDAL OATMEAL | JCS Global Distribution, Inc. | 535e42a1-8b14-324d-e063-6394a90a3f65 | 2026-06-03 | Warnings | M016 |
| Petroleum Jelly Skin Protectant | WHITE PETROLATUM | Acme United Corporation | 535e94bb-21e8-90be-e063-6394a90a37bb | 2026-06-03 | Warnings | M016 |
| ADVANCED HEALING | PETROLATUM | Rejoice International Corp. | 532c7e5a-4d05-3bd0-e063-6294a90aee00 | 2026-06-01 | Warnings | M016 |
| PUTRIZEN 40 UREA | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 533dadbc-6f20-d880-e063-6394a90a753f | 2026-06-01 | Warnings | M016 |
| ADVANCED HEALING BALM | PETROLATUM | Rejoice International Corp. | 53285d82-3755-ca78-e063-6394a90a5019 | 2026-05-31 | Warnings | M016 |
| KIEHLS SINCE 1851 Ultra Facial Meltdown Recovery | COLLOIDAL OATMEAL | LOreal USA Products Inc | 22e088b9-b3b1-4c34-be12-a5a31200ec25 | 2026-05-29 | Warnings | M016 |
| Acne Relief Cream | NIACINAMIDE,SALICYLIC ACID,CENTELLA ASIATICA ROOT,COPTIS CHINENSIS ROOT | Guangzhou Senmai Biotechnology Co.,Ltd. | 53008b89-89ab-7650-e063-6294a90ac16c | 2026-05-29 | Warnings | M016 |
| PURE PETROLATUM | PETROLATUM | VASA COSMETICS PRIVATE LIMITED | 52efd466-49bd-bbdf-e063-6394a90aa108 | 2026-05-28 | Warnings | M016 |
| TheraCare Vitamin A and D plus E | PETROLATUM | Veridian Healthcare | 52e0e248-6c04-feb9-e063-6394a90add46 | 2026-05-28 | 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 |