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 |
|---|---|---|---|---|---|---|
| Aveeno Daily Moisturizing | DIMETHICONE | Kenvue Brands LLC | 70593b0c-c41b-4294-9bfa-42003ba1e3e4 | 2024-11-05 | Warnings | M016 |
| Aveeno Baby Calming Comfort | DIMETHICONE | Kenvue Brands LLC | 029fbae2-06ad-4fe9-b542-834686c5cb97 | 2024-11-05 | Warnings | M016 |
| Aveeno Skin Relief Overnight | DIMETHICONE | Kenvue Brands LLC | e7da6c9c-d6b0-4dc5-bfa4-68345f9c2d3c | 2024-11-05 | Warnings | M016 |
| Quality Choice Diaper Rash | ZINC OXIDE | Chain Drug Marketing Association Inc. | 262e7eac-4b44-f224-e063-6394a90a4f59 | 2024-11-05 | Warnings | M016 |
| Zinc Oxide 20% | ZINC OXIDE | Chain Drug Marketing Association Inc. | 262f8cab-c7b8-b07e-e063-6294a90a1289 | 2024-11-05 | Warnings | M016 |
| ECZEMA | OATMEAL | ORGANIC & SUSTAINABLE BEAUTY | 926706b5-0a08-4604-b5ad-3b3ddfd7f02d | 2024-11-05 | Warnings | M016 |
| Walgreens Eczema Relief Body Skin Protectant | OATMEAL | Walgreen Company | b2eebc2f-addd-4822-b224-04bd5f450653 | 2024-11-05 | Warnings | M016 |
| ECZEMA | OATMEAL | ORGANIC & SUSTAINABLE BEAUTY | 81eb3df4-5beb-45aa-82ca-e8b4b37e45f4 | 2024-11-05 | Warnings, Adverse reactions | M016 |
| Aveeno Baby Calming Comfort | DIMETHICONE | Kenvue Brands LLC | 567b1481-b783-45f9-af38-5630c9edf044 | 2024-11-01 | Warnings | M016 |
| ZO Skin Health Astringent Solution | ALUMINUM ACETATE | ZO Skin Health, Inc. | cb801d7e-52ad-6c16-e053-2a95a90a7a1f | 2024-10-31 | Warnings | M016 |
| ZINC OXIDE PHARMA | ZINC OXIDE | ALLIED TRADE LINK LLC | 1b580bf6-f217-5c0f-e063-6294a90a012e | 2024-10-29 | Warnings | M016 |
| Dove DermaSeries Eczema Relief Soothing Body | COLLOIDAL OATMEAL | Conopco, Inc. d/b/a/ Unilever | 59f737f6-dd3f-4b63-b13e-2345cb9a951a | 2024-10-24 | Warnings | M016 |
| Dove | HAND SANITIZER SHEA BUTTER | Conopco Inc. d/b/a/ Unilever | a735d885-bacd-0f5c-e053-2a95a90ad14a | 2024-10-24 | Warnings | M016 |
| Baby Dove | 8H MOISTURIZATION HAND SANITIZER | Conopco Inc. d/b/a/ Unilever | b8dc481c-1ac3-2d63-e053-2a95a90a44f5 | 2024-10-24 | Warnings | M016 |
| Vaseline | CLINICAL CARE HAND SANITIZER LOTION | Conopco Inc. d/b/a/ Unilever | ba0aa323-8887-597f-e053-2995a90a2077 | 2024-10-24 | Warnings | M016 |
| Dove | NOURISHING HAND SANITIZER SENSITIVE SKIN 8HR MOISTURIZATION | Conopco Inc. d/b/a/ Unilever | d1039316-3ca8-90f8-e053-2995a90a2061 | 2024-10-24 | Warnings | M016 |
| Dove | HAND SANITIZER LAVENDER | Conopco Inc. d/b/a/ Unilever | a736838b-b559-f066-e053-2995a90a90f5 | 2024-10-24 | Warnings | M016 |
| Diaper Rash Cream 2.5oz | ZINC OXIDE | Rejoice International Corp. | 130d94d8-ad98-d61f-e063-6294a90a76b0 | 2024-10-21 | Warnings | M016 |
| HARMON DAILY MOISTURZIER | DIMETHICONE | HARMON STORES, INC. | bda5dbaa-5d62-4a40-ba55-e2066e8ca1c7 | 2024-10-21 | Warnings | M016 |
| Dimethicone | BODY SHIELD | McKesson | 8febb45d-a200-702c-e053-2995a90a3e62 | 2024-10-18 | 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 |