Calamine Plus
- Product NDC
- 79481-0615
- 11-digit product format
- 794810615
- Labeler code
- 79481
- Product ID
- 79481-0615_42660d75-8443-3e31-e063-6294a90a284d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Calamine Plus Pramoxine HCL
- Dosage form
- AEROSOL, SPRAY
- Route
- TOPICAL
- Labeler
- Meijer Distribution Inc.
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-08-25
- Substance
- FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE; ZINC OXIDE
- Active strength
- 5; 10; 79.5 mg/g; mg/g; mg/g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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 Plus
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FERRIC OXIDE RED | 5 mg/g |
| PRAMOXINE HYDROCHLORIDE | 10 mg/g |
| ZINC OXIDE | 79.5 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1K09F3G675 | Internal UNII lookup |
| 88AYB867L5 | Internal UNII lookup |
| SOI2LOH54Z | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 03c46823-0b1f-4101-e063-6294a90aaf94 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 7792dadb-52b6-46b6-8fdf-80b1171065b5 | Product name | 1 | 20180810 |
| 58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8 | Product name | 1 | 20140508 |
| 9869efd7-d6dd-0665-5b67-53adbe6ef15e | Product name | 1 | 20140508 |
| a7051cba-790b-a699-81f8-dbbbdbd9b5ac | Product name | 1 | 20140508 |
| da108d9e-edc8-17a3-8c28-3251c6a8accc | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 79481-0615-1 | Calamine Plus | 116 g in 1 CANISTER | AEROSOL, SPRAY | 116 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 79481-0615 | CALAMINE PLUS (CALAMINE PLUS PRAMOXINE HCL) AEROSOL, SPRAY [MEIJER DISTRIBUTION INC.] | 2 | Current NDC, 1 package rows | 20241016_03c46823-0b1f-4101-e063-6294a90aaf94.zip |
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 |
|---|---|---|---|---|---|---|
| Cool n Heat | COOL N HEAT | NeilMed Pharmaceuticals, Inc. | a24cde17-280b-8358-e053-2a95a90af67d | 2024-01-11 | Warnings | M017 |
| NeilMed Anti-Itch | ANTI-ITCH SPRAY | NeilMed Pharmaceuticals Inc. | b3d34d9e-85d9-df4e-e053-2a95a90ac8d9 | 2024-01-11 | Warnings | M017 |
| NeilMed Hot and Cold Pain Relief | PAIN RELIEF SPRAY | NeilMed Pharmaceuticals Inc. | b3d02111-7499-c2d4-e053-2a95a90ae1de | 2024-01-11 | Warnings | M017 |
| Cooling Itch Relief | COOLING ITCH RELIEF | NeilMed Pharmaceuticals, Inc | a24bdea0-18e8-8a5e-e053-2995a90acea2 | 2024-01-11 | Warnings | M017 |
| Lightning X Burn | LIDOCAINE | Nantong Health & Beyond Hygienic Products Inc. | 0e69a971-0c6e-6ebe-e063-6394a90a0b33 | 2024-01-08 | Warnings | M017 |
| Theraworx Pain Relief Roll-On with Lidocaine for Diabetics | LIDOCAINE HYDROCHLORIDE | AVADIM HOLDINGS, INC. | e07f5bf7-5a9a-468c-8c3f-2c6f0b17af29 | 2024-01-08 | Warnings | M017 |
| 2nd CHANCE MOBILITY Pain Relief | HISTAMINE DIHYDROCHLORIDE | ALPHA NUTRITION, LLC | 575097ac-9fc9-4391-99d1-dff9b34817e3 | 2024-01-08 | Warnings | M017 |
| Tiger Balm Arthritis Rub | CAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORM | Haw Par Healthcare Ltd. | 80932288-4797-40d3-aa8a-6af686fb67ad | 2024-01-08 | Warnings | M017 |
| OPRAVA | METHYL SALICYLATE, MENTHOL, CAPSAICIN | Biological M.D. Solutions LLC | 05552560-e283-5eba-e063-6294a90a65f7 | 2024-01-06 | Warnings | M017 |
| MED O-3 BIO- | METHYL SALICYLATE, MENTHOL, CAPSAICIN | Biological M.D. Solutions LLC | 02707552-03d9-3ad2-e063-6294a90a3472 | 2024-01-06 | Warnings | M017 |
| Sumifun Knee Relieving Patch | KNEE RELIEVING PATCH | Zhengzhou Miaoqi Pharmaceutical Technology Co., Ltd | 0e7e73ec-ab33-9235-e063-6394a90ad950 | 2024-01-06 | Warnings | M017 |
| Lidocaine Numbing Cream | LIDOCAINE | YYBA Corp | de6dc194-c6ef-4cb5-be3f-e772ace9abaf | 2024-01-03 | Warnings | M017 |
| Equate Vagicaine | 20% BENZOCAINE AND 3% RESORCINOL CREAM | Walmart Inc. | 0cdc9323-f5c3-468c-a7ae-83dfd2d76626 | 2024-01-03 | Warnings | M017 |
| OWELL NATURALS Deep Penetrating Pain Relief | MENTHOL | OWELL NATURALS BRAND, LLC | b36eb017-ed8d-476e-994b-22b275e00543 | 2024-01-02 | Warnings | M017 |
| Dibucaine | DIBUCAINE 1% | Trifecta Pharmaceuticals USA LLC | e8a56651-a292-7609-e053-2a95a90a7c36 | 2024-01-02 | Warnings | M017 |
| Anti-Itch Cream | DIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1% | Trifecta Pharmaceuticals USA, LLC. | 44d17651-a31b-64ca-e054-00144ff8d46c | 2024-01-02 | Warnings | M017 |
| Muscle Rub Cream | MENTHOL 10%, METHYL SALICYLATE 15% | Trifecta Pharmaceuticals USA, LLC. | e0a13344-5493-eb51-e053-2995a90a8183 | 2024-01-02 | Warnings | M017 |
| Sumifun Knee Relieve Patch | KNEE RELIEVE PATCH | Zhengzhou Miaoqi Pharmaceutical Technology Co., Ltd | 0e031aa5-edf4-8c9d-e063-6394a90afee3 | 2024-01-02 | Warnings | M017 |
| OKeeffes Healthy Feet | ALLANTOIN, LIDOCAINE | The Gorilla Glue Company/O'Keeffe's Company | d73709db-3932-3c56-e053-2995a90a7d0a | 2024-01-01 | Warnings | M017 |
| PERSONAL CARE ICE COLD | MENTHOL | NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD. | 1994356c-e347-5b7d-e063-6394a90a476c | 2024-01-01 | Warnings | M017 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 79481-0615-1 | 79481061501 | 116 g in 1 CANISTER (79481-0615-1) | 116 g | 2023-08-25 | No | No | Current |