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 |
|---|---|---|---|---|---|---|
| Daily Moisturizing | DIMETHICONE | Topco Associates LLC | 47e54eee-70e0-4bfa-ae77-d61a6560a9e1 | 2026-02-13 | Warnings, Adverse reactions | M016 |
| Witch Hazel | WITCH HAZEL | Topco Associates LLC | 471a9f8d-ba12-41d3-a510-20c1a13ff850 | 2026-02-13 | Warnings, Adverse reactions | M016 |
| Skin Protectant | PETROLATUM | Wakefern Food Corp. | b799229b-f7ca-494c-afde-1fd096aef66e | 2026-02-13 | Warnings, Adverse reactions | M016 |
| Diaper Rash | ZINC OXIDE | WinCo Foods, LLC | 659cc8c7-6300-41c0-a684-c5fde7f2b100 | 2026-02-12 | Warnings, Adverse reactions | M016 |
| Zinc Oxide | ZINC OXIDE | Walgreen Co. | 220f70e1-0802-4fe2-92d0-78dec557c993 | 2026-02-12 | Warnings, Adverse reactions | M016 |
| Witch Hazel | WITCH HAZEL | Walgreen Co. | 417ae199-54bb-420f-a3cf-1c096062d78c | 2026-02-12 | Warnings, Adverse reactions | M016 |
| First Aid Beauty Dry Skin Rescue Kit | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | 4a93d029-d721-0bb5-e063-6294a90a17c4 | 2026-02-11 | Warnings | M016 |
| Natouch Eczema Wipes | ECZEMA WIPES | Natouch LLC | 0a9756a4-2fa9-cd19-e063-6294a90a93ad | 2026-02-10 | Warnings | M016 |
| EARTHS CARE Eczema Cream | ECZEMA | DLC Laboratories, Inc. | 17436fa0-d6c7-1052-e063-6294a90adae4 | 2026-02-09 | Warnings | M016 |
| Petrolatum | WHITE PETROLATUM | Retail Business Services, LLC | bf0c9494-0138-4346-9348-e235ca4d9e58 | 2026-02-06 | Warnings, Adverse reactions | M016 |
| Clear Anti-Itch | PRAMOXINE HCL, ZINC ACETATE | Retail Business Services, LLC | a80b8fee-2dd9-4640-a4f8-4cf940df8563 | 2026-02-06 | Warnings, Adverse reactions | M016 |
| Advanced Healing | PETROLATUM | Retail Business Services, LLC | 6e9121c8-5eb9-4d0b-86c5-b892e14bdab8 | 2026-02-06 | Warnings | M016 |
| Petrolatum | WHITE PETROLATUM | Retail Business Services, LLC | bf73c618-ed2f-4468-a51f-ff61c7b1f506 | 2026-02-06 | Warnings, Adverse reactions | M016 |
| Daily Moisturizing | DIMETHICONE | Retail Business Services, LLC | c8a876e2-0a34-4c3d-a0bc-549dd3048e8a | 2026-02-06 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | Salado Sales Inc. | f973e3a5-3b45-4842-99ce-dff676ae1f96 | 2026-02-06 | Warnings, Adverse reactions | M016 |
| Petroleum Skin Protectant | WHITE PETROLATUM | Pharmacy Value Alliance, LLC | 0ce03cd1-c48d-45cf-b11f-08bade55dcb6 | 2026-02-05 | Warnings, Adverse reactions | M016 |
| Daily Moisturizing | DIMETHICONE | Publix Super Markets, Inc. | 28ac9de4-2a63-4839-bed5-9bcc59ebeb2a | 2026-02-05 | Warnings, Adverse reactions | M016 |
| Witch Hazel | WITCH HAZEL | Publix Super Markets, Inc. | 0098c983-c518-4a14-8635-c7bdde7bff4f | 2026-02-05 | Warnings, Adverse reactions | M016 |
| TN Dickinsons Pain and Itch Relief | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE | Dickinson Brands Inc. | 537c9c27-ee81-4920-8e3f-21edb844c9cf | 2026-02-05 | Warnings | M016 |
| Aveeno Eczema Therapy Nighttime Itch Relief Balm | COLLOIDAL OATMEAL | Kenvue Brands LLC | e3350a8f-b983-7c4d-e053-2a95a90a53f5 | 2026-02-04 | 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 |