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 |
|---|---|---|---|---|---|---|
| Professional Therapy MuscleCare Pain Relieving | MENTHOL, CAMPHOR | Active and Innovative Inc. | 42f1abeb-f6d7-01c3-e054-00144ff88e88 | 2025-01-23 | Warnings | M017 |
| LIDOCAINE | LIDOCAINE | PHARMACURE LLC | 53384c51-6da1-4fa4-8782-2606ca3d1c6f | 2025-01-22 | Warnings | M017 |
| Capsaicin | CAPSAICIN | PHARMACURE LLC | 829afe1b-6b2a-42a9-9626-8e39b0105e70 | 2025-01-22 | Warnings | M017 |
| FORTHiQ Pain Relief Lidocaine Patch | PAIN RELIEF LIDOCAINE PATCH | Henan Enokon Medical Instrument Co., Ltd. | 2c593420-5788-3422-e063-6394a90a1890 | 2025-01-22 | Warnings | M017 |
| RETALIEF LIDOCAINE 5 | LIDOCAINE | Reliable 1 Laboratories LLC | 2c262f3c-8cb2-4384-e063-6294a90a436d | 2025-01-20 | Warnings | M017 |
| Eagle Brand Medicated Roll On Aromatic | CAMPHOR, MENTHOL, METHYL SALICYLATE | Borden Company (Private) Limited | 1c3e5068-dd61-ebdb-e063-6294a90a97cc | 2025-01-20 | Warnings | M017 |
| PROHEAL BURN | LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE | Nantong Health & Beyond Hygienic Products Inc. | bbc0a5d6-1de6-4ca3-9bb4-a45662b5eab1 | 2025-01-19 | Warnings | M017 |
| HERSTAT PLUS Cold Sore Treatment | CAMPHOR, MENTHOL | Herstat (USA) Inc. | e20ea714-663d-c4ac-e053-2a95a90a5ecc | 2025-01-18 | Warnings | M017 |
| Pain Relief Medicated | CAMPHOR MENTHOL METHYL SALICYTATE | RITE AID CORPORATION | 60895211-69f3-478b-a33f-1c2071f62950 | 2025-01-16 | Warnings | M017 |
| Elgin Pain Relief | MENTHOL | Eco-Logics, Inc. | 70eda21e-e566-42f4-9a49-b0d3ad000652 | 2025-01-16 | Warnings | M017 |
| Curist Lidocaine Patch Maximum Strength | LIDOCAINE | Little Pharma, Inc. | e574c188-cc65-287d-e053-2995a90a5972 | 2025-01-16 | Warnings | M017 |
| Equate Hydrocortisone Topical | HYDROCORTISONE | WalMart | 1f64555d-f77e-4a83-b222-fdb3ed7d8853 | 2025-01-16 | Warnings | M017 |
| Equate Hydrocortisone | HYDROCORTISONE | WalMart | f5c32b4a-1159-4b7a-b8ac-256d53020dc2 | 2025-01-16 | Warnings | M017 |
| Lidocaine Pain Relief Gel-Patch | LIDOCAINE | Guangzhou Zhupuyou E-commerce Co., Ltd | 296fcc36-563f-19ca-e063-6394a90ab3ae | 2025-01-15 | Warnings | M017 |
| K19 RELIEF | MENTHOL | K19 LLC | e2e1ca96-1ae8-4c99-b8de-ce26754292f9 | 2025-01-15 | Warnings | M017 |
| Anecream | LIDOCAINE 4% | Focus Health Group | 2d7706e2-7363-4047-96cb-85b718277e8c | 2025-01-15 | Warnings | M017 |
| Boroleum | CAMPHOR, MENTHOL, WHITE PETROLATUM | Reliable 1 Laboratories | 846568af-0fdd-a80e-e053-2a91aa0a9c9e | 2025-01-15 | Warnings | M017 |
| LidoPro Pain Relief | CAPSAICIN AND LIDOCAINE | Advanced Rx of Tennessee, LLC | 27d5997b-1cc2-41c2-e063-6394a90ac74a | 2025-01-15 | Warnings | M017 |
| Pain Relief Patch 4% Lidocaine | LIDOCAINE | Reliable 1 Laboratories LLC | 2b624763-c310-63d9-e063-6394a90a1928 | 2025-01-15 | Warnings | M017 |
| Cannarelief 1000mg | MENTHOL | Carolina Cannabis Creations LLC | 01e2ae1a-c969-6dd2-e063-6394a90a9d9e | 2025-01-15 | 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 |