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 |
|---|---|---|---|---|---|---|
| Colloidal oatmeal | COLLOIDAL OATMEAL | CVS Pharmacy, Inc. | 4a43b1a2-2156-e490-e063-6294a90a6f84 | 2026-04-07 | Warnings, Adverse reactions | M016 |
| Calamine | CALAMINE 8%, ZINC OXIDE 8% | Farmacias De Similares TX LLC | 4ecd0add-11c9-cf3b-e063-6394a90adff6 | 2026-04-06 | Warnings | M016 |
| Petroleum | WHITE PETROLATUM | CVS Pharmacy, Inc. | 4dc08832-e610-4e62-a6af-cadaa339e39e | 2026-04-06 | Warnings, Adverse reactions | M016 |
| Witch Hazel | WITCH HAZEL SPRAY | CVS Pharmacy | 53db78a8-eb2d-431b-84c1-73e99bb9d3d1 | 2026-04-06 | Warnings | M016 |
| Petroleum | WHITE PETROLATUM | Amazon.com Services LLC | 616ef87d-1518-46aa-8e12-9a1b678d4980 | 2026-04-06 | Warnings, Adverse reactions | M016 |
| Stabilizing Repair Serum | OATMEAL | Dermalogica, LLC. | 86b7b230-5424-46d3-8058-656f5172fc70 | 2026-04-02 | Warnings | M016 |
| calamine | CALAMINE AND ZINC OXIDE | STRATEGIC SOURCING SERVICES | 4e6a7bdf-4ef1-65e2-e063-6394a90ae124 | 2026-04-01 | Warnings | M016 |
| Aveeno Eczema Therapy Rescue Relief Treatment Gel Cream | COLLOIDAL OATMEAL | Kenvue Brands LLC | 4e4e1797-26e6-a67b-e063-6294a90af438 | 2026-03-31 | Warnings | M016 |
| Target Advanced Scar Gel | ADVANCED SCAR GEL | Target Corporation | 86c215fe-aad4-45d1-bdb7-cde00a115c5c | 2026-03-31 | Warnings | M016 |
| Zinc oxide, Dimethicone | ZINC OXIDE, DIMETHICONE | Walmart Inc. | 4cbf9492-33cd-e6d4-e063-6294a90ab001 | 2026-03-31 | Warnings, Adverse reactions | M016 |
| Critic-Aid Clear | PETROLATUM | Coloplast Corp | a92c18f7-52b2-43e4-bae3-2bab9de22671 | 2026-03-31 | Warnings | M016 |
| 3M Cavilon Durable Barrier | DIMETHICONE | Solventum US LLC | f3f8be33-4ad2-4f5f-ac94-ddfbe0280b83 | 2026-03-31 | Warnings | M016 |
| XIMONTH Foot Sanitizer | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 4e38d24d-3745-c121-e063-6394a90abbb5 | 2026-03-30 | Warnings | M016 |
| Dynashield | ZINC OXIDE | Dynarex Corporation | 59fd865c-b81d-43ad-8fa0-c37ca0557769 | 2026-03-30 | Warnings | M016 |
| First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant | COLLOIDAL OATMEAL | Port Jervis Laboratories, Inc | 4e43b65c-d5bb-f228-e063-6294a90ad08d | 2026-03-30 | Warnings | M016 |
| ChapStick Classic Original | SKIN PROTECTANT LIP BALM | Suave Brands Co., LLC | 4275956d-275a-4e31-e063-6394a90a78d3 | 2026-03-30 | Warnings | M016 |
| ChapStick Classic Cherry | SKIN PROTECTANT LIP BALM | Suave Brands Co., LLC | 42762471-e5cd-505e-e063-6294a90afb7d | 2026-03-30 | Warnings | M016 |
| ChapStick Classic Variety Cherry-Strawberry-Spearmint | SKIN PROTECTANT LIP BALM | Suave Brands Co., LLC | 450e46d2-de86-e5fa-e063-6294a90ac6ff | 2026-03-30 | Warnings | M016 |
| ChapStick Classic Original | SKIN PROTECTANT LIP BALM | Suave Brands Co., LLC | 4512220a-9fc2-8816-e063-6394a90a9d15 | 2026-03-30 | Warnings | M016 |
| ChapStick Classic Original Military | SKIN PROTECTANT LIP BALM | Suave Brands Co., LLC | 45136b7e-136b-0283-e063-6394a90a599a | 2026-03-30 | 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 |