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 |
|---|---|---|---|---|---|---|
| Assured | HYDROCORTISONE | Zhejiang Jingwei Pharmaceutic Al Co., Ltd. | bc97f364-9443-47b8-9c2d-b5dcc00cc9b7 | 2023-10-25 | Warnings | M017 |
| Stopain Clinical | MENTHOL, UNSPECIFIED FORM | Troy Manufacturing, Inc. | b41091b4-0dc0-4a88-8ff6-11979b3d307a | 2023-10-25 | Warnings | M017 |
| Thera Plus | HYDROCORTISONE | Zhejiang Jingwei Pharmaceutical Co., Ltd. | bcc99e5a-2403-46da-9c9d-8411fa4104e0 | 2023-10-25 | Warnings | M017 |
| Assured | LIDOCAINE HYDROCHLORIDE | Zhejiang Jingwei Pharmaceutical Co., Ltd. | ab25c47d-bbe6-4e2b-9e39-dd9f4da3ee8c | 2023-10-25 | Warnings | M017 |
| Red hot | CAPSAICIN | The Hygenic Company, LLC | d100092c-e10b-2063-e053-2995a90aedb2 | 2023-10-25 | Warnings | M017 |
| Stopain Clinical | MENTHOL | Troy Manufacturing, Inc. | c8d4ae28-efc4-6a00-e053-2a95a90a40bf | 2023-10-25 | Warnings | M017 |
| Cryo10 Topical Analgesic | MENTHOL | Element 26 LLC | ff1d2140-9302-918c-e053-6394a90acb9a | 2023-10-25 | Warnings | M017 |
| Stopain Clinical | MENTHOL | Troy Manufacturing, Inc. | 3336cc35-e773-4705-84b5-61040604beef | 2023-10-25 | Warnings | M017 |
| CARMEX Multi-Symptom 3 in 1 COLD Sore treatment External Analgesic Skin Protectant | BENZOCAINE, WHITE PETROLATUM | Carma Laboratories, Inc. | bbf0abcd-b7d6-b5e4-e053-2995a90a5240 | 2023-10-25 | Warnings | M017 |
| Carmex Classic Lip Balm Medicated | CAMPHOR (SYNTHETIC), WHITE PETROLATUM | Carma Laboratories, Inc. | bbee66b9-39ff-4e7e-e053-2995a90a43be | 2023-10-25 | Warnings | M017 |
| XtraCare Ice Cold Topical Analgesic Gel | MENTHOL | Rejoice International | d38f3099-d940-44d8-aa7f-404157c5e0e3 | 2023-10-24 | Warnings | M017 |
| Family Wellness | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | Zhejiang Jingwei Pharmaceutical Co., Ltd. | fefbe351-1cd9-4a2f-a43d-51e2c4eb180b | 2023-10-24 | Warnings | M017 |
| TheraPlus Plus | MENTHOL | Zhejiang Jingwei Pharmaceutical Co., Ltd. | d4119f84-eb60-4134-b58e-de13d9601199 | 2023-10-24 | Warnings | M017 |
| Family Wellness | HYDROCORTISONE | Zhejiang Jingwei Pharmaceutical Co., Ltd. | cddc9c4a-7c58-4225-921a-05d6afb49178 | 2023-10-24 | Warnings | M017 |
| NUMOTIZINE | MENTHOL | Hobart Laboratories, Inc. | 9a29ad1b-4ba3-403f-90c9-ee7582fe4535 | 2023-10-20 | Warnings | M017 |
| Numfast Tetracaine Green | TETRACAINE | Unit Dose, Ltd. | 77d9e6ea-1cd3-4447-ba74-01cd7143e27c | 2023-10-19 | Warnings | M017 |
| Liprotek | PETROLATUM, LIDOCAINE | Unit Dose, Ltd. | 051cfa27-bd7c-4f8c-b3e6-03ee0b7a3aa5 | 2023-10-19 | Warnings | M017 |
| GENUINE FIRST AID Antiseptic Pain Relieving | BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE | Nantong Health & Beyond Hygienic Products Inc. | bc7c6739-6068-4694-adc9-0c0c5c347df4 | 2023-10-19 | Warnings | M017 |
| CVS Itch relief moisturizing | PRAMOXINE HCL 1% | CVS Health | f3a753fc-f448-6bba-e053-2a95a90a8e1b | 2023-10-18 | Warnings | M017 |
| Zylotrol | LIDOCAINE HCL 4%, MENTHOL 1% | Asclemed USA, Inc. | e13984ea-73a9-2894-e053-2995a90a8ed6 | 2023-10-16 | 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 |