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 |
|---|---|---|---|---|---|---|
| LIDOGUARD | LIDOCAINE 4% | ViolaCare, Inc. | d8b021b6-cf71-4f7e-9d27-92d0982bd34f | 2026-03-25 | Warnings | M017 |
| LactiGo | MENTHOL | LactiGo, Inc. | 4dda6ac4-d849-69a6-e063-6394a90a3c54 | 2026-03-25 | Warnings | M017 |
| Alocane Max | LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE | Quest Products LLC | 0a33f9a9-1fdc-7cdf-e063-6294a90adca1 | 2026-03-25 | Warnings | M017 |
| EjaGuard | LIDOCAINE | MOLANSPACE INC | 475f64ef-d636-7e87-e063-6294a90ae32f | 2026-03-25 | Warnings | M017 |
| Hydrocortisone 1% | HYDROCORTISONE | ProStat First Aid | 4e53d29c-ed3c-f481-e063-6294a90a3181 | 2026-03-25 | Warnings | M017 |
| Topicaine Ultra | TOPICAINE ULTRA | Oncora Pharma, LLC | e052f718-700a-44e0-8770-65451b812ee1 | 2026-03-24 | Warnings | M017 |
| Hot Pap Cataplasma | METHYL SALICYLATE, VANILLYL NONYLAMIDE | Masaem Company | 4dbeda13-b198-0cf0-e063-6294a90a8180 | 2026-03-24 | Warnings | M017 |
| Barmicil Anti-itch | HYDROCORTISONE | OPMX LLC | 850084c3-1dd4-eb8d-e053-2a91aa0a130b | 2026-03-24 | Warnings | M017 |
| Jeil Hangbang Paff Soo S Cataplasma | GLYCOL SALICYLATE, L-MENTHOL | Masaem Company | 4dd040db-07cf-361a-e063-6394a90a8001 | 2026-03-24 | Warnings | M017 |
| Zenol Double Action | METHYL SALICYLATE, L-MENTHOL | BA TRADE INC | 4da998fc-75a3-583f-e063-6394a90a59c7 | 2026-03-23 | Warnings | M017 |
| Ultra Strength Topical Pain Relief Cream | CAMPHOR, MENTHOL, METHYL SALICYLATE | J C UDEOZOR & SONS GLOBAL INDUSTRIES LTD | 4db9ae57-4ab4-8fe4-e063-6394a90a7e51 | 2026-03-23 | Warnings | M017 |
| DR. SANA ALIVIO TOTAL ALIVIO TOTAL ROLL ON | ALIVIO TOTAL ROLL ON | EVI LABS | 4da01338-8739-08a8-e063-6294a90ae157 | 2026-03-22 | Warnings | M017 |
| DR SANA ALIVIO TOTAL ALIVIO TOTAL | ALIVIO TOTAL | EVI LABS | 4da1c3b8-9af2-6e9f-e063-6394a90a86ae | 2026-03-22 | Warnings | M017 |
| SORE NO MORE | MENTHOL CAMPHOR | SOMBRA COSMETICS INC. | 80d97c80-bdc0-4d5d-b6e2-86dfdb15d7bd | 2026-03-20 | Warnings | M017 |
| CVS Health Antiseptic Wound Wash | LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE | CVS Pharmacy | 53ac017a-eccb-3b24-e054-00144ff88e88 | 2026-03-20 | Warnings | M017 |
| Tecnu Diphenhydramine HCl Pain Relieving Anti Itch Gel 2% | ANTI ITCH GEL | Walgreens | 3d6e8c62-2fcc-51c2-e063-6394a90a33f7 | 2026-03-20 | Warnings | M017 |
| ANIXIKE Numbing | MENTHOL 5% NUMBING | Jiangxi Yudexi Pharmaceutical Co., LTD | 4d5c52d7-8e81-b62f-e063-6394a90ad03e | 2026-03-19 | Warnings | M017 |
| SYLVIRENE NUMBING | MENTHOL 5% NUMBING | Jiangxi Yudexi Pharmaceutical Co., LTD | 4d47e8c7-d293-bf63-e063-6294a90a5fd9 | 2026-03-18 | Warnings | M017 |
| Antibiotic and Pain Relief | NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE | STRATEGIC SOURCING SERVICES LLC | f7aa9330-c47c-4d2f-b784-11b831d919d6 | 2026-03-18 | Warnings | M017 |
| hydrocortisone | HYDROCORTISONE | Bryant Ranch Prepack | 99726aa3-3b45-4175-8471-279419af5457 | 2026-03-18 | 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 |