Calamine Plus Pramoxine HCl
- Product NDC
- 36800-398
- 11-digit product format
- 368000398
- Labeler code
- 36800
- Product ID
- 36800-398_5c529fcd-903f-5e7d-e063-6394a90a3155
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Calamine Plus Spray
- Dosage form
- AEROSOL, SPRAY
- Route
- TOPICAL
- Labeler
- Topco Associates LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2017-01-01
- Substance
- FERRIC OXIDE RED; ZINC OXIDE; PRAMOXINE HYDROCHLORIDE
- Active strength
- .345; 24.16; 2.72 mg/116g; mg/116g; mg/116g
- 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 Plus Pramoxine HCl
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FERRIC OXIDE RED | .345 mg/116g |
| ZINC OXIDE | 24.16 mg/116g |
| PRAMOXINE HYDROCHLORIDE | 2.72 mg/116g |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f47a510b-6679-4664-b2d6-47b5c4afe7cc | Product name | 4 | 20260217 |
| 030ce964-9b2d-45aa-b5d3-f78ce03ef61c | Product name | 2 | 20250515 |
| 0306390c-dd77-4363-afe0-63c58088b2a1 | Product name | 1 | 20220120 |
| 503ea967-4b9c-48cf-9e87-c7975295849d | Product name | 2 | 20220120 |
| 190f2a5b-bbc8-65c7-fcb0-97891307b917 | Product name | 1 | 20140508 |
| 58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8 | 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 |
|---|---|---|---|---|---|---|
| 36800-398-41 | Calamine Plus Pramoxine HCl | 116 g in 1 CANISTER | AEROSOL, SPRAY | 116 | 11 |
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 |
|---|---|---|---|---|---|---|
| RELIBONEOintment | TOPICAL ANALGESICOINTMENT | Guangdong Jiaoyu Biotechnology Co., Ltd | 58ddaaf6-18ec-8c5b-e063-6294a90a2828 | 2026-08-12 | Warnings | M017 |
| Capsaicin Cream | CAPSAICIN | Trifecta Pharmaceuticals USA LLC | 58de3a29-2bec-6e44-e063-6394a90a9c1a | 2026-08-12 | Warnings | M017 |
| HYDROCORTISONE | HYDROCORTISONE | Amazon.com Services LLC | f40b4223-e81f-4cd0-bc9b-d3d33ce8cce5 | 2026-08-12 | Warnings | M017 |
| Muscle Rub Cream | MUSCLE RUB | ALLIED TRADE LINK LLC | 11d33e60-8c64-4316-a29a-d17e3e6e4a28 | 2026-08-11 | Warnings | M017 |
| Gee Gason | MALE GENITAL DESENSITIZER | Mon Gars Boutique Inc | 58c75e5c-b801-017f-e063-6394a90a1c75 | 2026-08-11 | Warnings | M017 |
| Capsaicin Cream | CAPSAICIN | Trifecta Pharmaceuticals USA LLC | 58c84330-15bf-c397-e063-6394a90aba05 | 2026-08-11 | Warnings | M017 |
| Hydrocortisone with Aloe | HYDROCORTISONE | TARGET Corporation | 4a140b9a-0e3c-4b50-b9c0-9e72616bb7d5 | 2026-08-11 | Warnings | M017 |
| Itch Relief | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | CVS Pharmacy | 0e988da1-1904-431d-a152-bdb2aacc8e16 | 2026-08-11 | Warnings | M017 |
| Medicated BODY | MENTHOL | CVS Pharmacy, Inc. | a0f61498-69c8-4ce0-bbd7-3a807f192d36 | 2026-08-11 | Warnings | M017 |
| Muscle Move | MENTHOL | Saje Natural Wellness Inc. | 526d3305-4cf8-2fc5-e063-6394a90ad53b | 2026-08-10 | Warnings | M017 |
| Relieve and Relax Pain Relieving | CAMPHOR (SYNTHETIC), MENTHOL | MAC Innovations, LLC | c0528c36-d322-8110-e053-2995a90add6c | 2026-08-08 | Warnings | M017 |
| CVS Pain Relief | MENTHOL | CVS Pharmacy | 4aa629f5-8b8f-cc67-e063-6394a90a019f | 2026-08-07 | Warnings | M017 |
| Instant Cooling Itch Relief | HYDROCORTISONE | CVS Pharmacy | 46545d04-5958-d136-e063-6394a90a3462 | 2026-08-07 | Warnings | M017 |
| CVS Itch Relief | PRAMOXINE HYDROCHLORIDE, ZINC ACETATE | CVS Pharmacy | 46921bea-fcbe-94d6-e063-6394a90a726b | 2026-08-07 | Warnings | M017 |
| CVS Isopropyl Rubbing Alcohol | ISOPROPYL ALCOHOL | CVS Pharmacy | 524605f9-8b04-b600-e063-6394a90a4a02 | 2026-08-07 | Warnings | M017 |
| Lidonex | LIDOCAINE HCL, MENTHOL | Aldama Pharmaceuticals, Inc | 365cf19c-70e0-c4e9-e063-6294a90ac428 | 2026-08-07 | Warnings | M017 |
| Blaster Pain Relief Stick | MENTHOL, METHYL SALICYLATE, CAMPHOR | Kalahari Rose, LLC | 587d660a-5f80-de5a-e063-6394a90aa287 | 2026-08-07 | Warnings | M017 |
| Itch Relief | DIPHENHYDRAMINE HCL, ZINC ACETATE | Cardinal Health, 110 dba Leader | 3ed7b8a1-012f-459d-878c-813b93d4673c | 2026-08-06 | Warnings, Adverse reactions | M017 |
| Gel Cooling Pain Relief | MENTHOL | The Kroger Co. | 6fb0acc8-8dab-452c-b09e-de97306e1c32 | 2026-08-06 | Warnings, Adverse reactions | M017 |
| Lidocaine Tattoo Wipe | LIDOCAINE HYDROCHLORIDE | MD Tattoo Company | 369c1d16-597c-e1dc-e063-6394a90a3104 | 2026-08-06 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1544717 | calamine 8 % / pramoxine HCl 1 % Topical Spray | PSN | af314adb-bd65-4233-b7e1-6cfb819615a3 | 11 |
| 1544717 | calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Spray | SCD | af314adb-bd65-4233-b7e1-6cfb819615a3 | 11 |
| 1544717 | calamine 8 % / pramoxine hydrochloride 1 % Topical Spray | SY | af314adb-bd65-4233-b7e1-6cfb819615a3 | 11 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 36800-398-41 | 36800039841 | 116 g in 1 CANISTER (36800-398-41) | 116 g | 2017-01-01 | 0000-00-00 | No | No | Current |