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 |
|---|---|---|---|---|---|---|
| Pain Itch Relief | LIDOCAINE HCI | Trifecta Pharmaceutical USA LLC | f40b19a8-795c-f514-e053-2a95a90a6d15 | 2024-12-20 | Warnings | M017 |
| Muscle Rub Cream | MENTHOL 10%, METHYL SALICYLATE 15% | Trifecta Pharmaceuticals USA, LLC. | 44d3638d-f29b-0e01-e054-00144ff88e88 | 2024-12-20 | Warnings | M017 |
| Rhuli Gel | CAMPHOR, MENTHOL | Trifecta Pharmaceuticals USA, LLC. | 4fbb3c23-ed47-336e-e054-00144ff8d46c | 2024-12-20 | Warnings | M017 |
| Hydrocortisone Cream with Aloe | HYDROCORTISONE | Rugby Laboratories | 132982ea-cce6-687c-e063-6294a90a4632 | 2024-12-20 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE 1% | Pharmacy Value Alliance LLC | 9bb98452-a605-5c20-e053-2995a90a1ea7 | 2024-12-20 | Warnings | M017 |
| DCH Cooling Pain Relief | MENTHOL 10.5% | Derma Care Research Labs, LLC | 00dcdae0-c744-8402-e063-6294a90a12f8 | 2024-12-20 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE 1% | Pharmacy Value Alliance LLC | ab95e606-69f0-1d58-e053-2a95a90a073b | 2024-12-20 | Warnings | M017 |
| Itch Relief Cream | ZINC ACETATE 0.1%, DIPHENHYDRAMINE HYDROCHLORIDE 2% | Pharmacy Value Alliance LLC | 37fe6d82-adee-4f58-e054-00144ff88e88 | 2024-12-20 | Warnings | M017 |
| Warrior First Aid Anti Itch | DIPHENHYDRAMINE HCL 2%, ZINC ACETATE 0.1% | Derma Care Research Labs, LLC | ec6e9a5b-c61d-a385-e053-2995a90ac936 | 2024-12-20 | Warnings | M017 |
| DCH Burn Relief | LIDOCAINE HCL | Derma Care Research Labs, LLC | ff227154-cf3b-9796-e053-6294a90a5535 | 2024-12-20 | Warnings | M017 |
| Outback Pain Relief | CAMPHOR 6%, MENTHOL 16% | Derma Care Research Labs, LLC | c238c930-2012-2d48-e053-2a95a90a8a4a | 2024-12-20 | Warnings | M017 |
| Meijer Pain Relief | LIDOCAINE HCL 4% | Meijer | f31b11ed-2ff9-5cfc-e053-2a95a90af2ca | 2024-12-20 | Warnings | M017 |
| Meijer Pain Relief | MENTHOL 10.5% | Meijer | bed81975-bd63-cf5b-e053-2995a90ac5fa | 2024-12-20 | Warnings | M017 |
| Mirakel Pain and Itch Relief | BENZOCAINE 20%, RESORCINOL 3% | Sanvio, Inc. | ed34d728-0275-e209-e053-2995a90a93ff | 2024-12-20 | Warnings | M017 |
| Meijer Pain Relief | LIDOCAINE 4% | Meijer | bed67c31-c479-6f9b-e053-2a95a90a5516 | 2024-12-20 | Warnings | M017 |
| Blue-Emu Ultra with Hemp Seed | TROLAMINE SALICYLATE | Kingsway Pharmaceuticals dba NFI, LLC | 80a3cf99-16e8-412b-ab9f-3d9d5cbb7aa9 | 2024-12-20 | Warnings | M017 |
| Epsom Salts | MAGNESIUM SULFATE | International Wholesale Inc. | e4d9bc32-ac85-349f-e053-2995a90a032f | 2024-12-19 | Warnings | M017 |
| Epsom Salts | MAGNESIUM SULFATE | International Wholesale Inc. | e5f3edc2-1b79-533a-e053-2a95a90ae9b6 | 2024-12-19 | Warnings | M017 |
| Leader | LIDOCAINE HCL | Cardinal Health | cea6bd2d-a265-1209-e053-2995a90ab0a5 | 2024-12-19 | Warnings | M017 |
| Rugby Anti-Itch | CAMPHOR, MENTHOL | RUGBY LABORATORIES | 99d8ad9e-46ec-15fc-e053-2995a90a0d17 | 2024-12-19 | 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 |