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 |
|---|---|---|---|---|---|---|
| Valtrum IMMEDIATE ACTION TOPICAL ANALGESIC | CAMPHOR, MENTHOL, METHYL SALICYLATE | LABORATORIOS QUANTIUM LLC | c4efa317-8dd1-49e1-b7ca-9df2147edd3e | 2023-12-21 | Warnings | M017 |
| DDM Camphor Spirit | CAMPHOR 10% | Discount Drug Mart | 5d56cbe6-4e48-79eb-e053-2a91aa0a74d3 | 2023-12-20 | Warnings | M017 |
| Quality Choice Camphor Spirit | CAMPHOR 10% | Chain Drug Market Association | 8d352a67-2024-43d0-b525-038d398949e6 | 2023-12-20 | Warnings | M017 |
| Instant Antiseptic Pain Relief | CAMPHOR 10.8% AND PHENOL 4.7% | Chain Drug Market Association | 2cd60df3-bfde-4747-ba4f-7121612f2e63 | 2023-12-20 | Warnings | M017 |
| Poison Ivy Wash | PRAMOXINE HCL | Chain Drug Market Association | 873a546b-90ae-50cb-e053-2a91aa0adbfb | 2023-12-20 | Warnings | M017 |
| Premier Value Instant Antiseptic Pain Relief | CAMPHOR 10.8% AND PHENOL 4.7% | Pharmacy Value Alliance LLC | 9d63f8ed-fc50-0d84-e053-2a95a90a6e92 | 2023-12-20 | Warnings | M017 |
| Ear Drops | CARBAMIDE PEROXIDE 6.5% | CVS Pharmacy | 8a872991-01af-5fd0-e053-2995a90ac7f4 | 2023-12-20 | Warnings | M017 |
| CVS Cold and Hot Roll-On | COOL AND HEAT PAIN RELIEF | CVS Pharmacy | b8cc578a-be6d-90c0-e053-2995a90a7742 | 2023-12-20 | Warnings | M017 |
| Sunmark Camphor Spirit | CAMPHOR 10% | Strategic Sourcing Services LLC | 667b3a9f-4a5c-4ef0-adbd-cce9a5f94faa | 2023-12-19 | Warnings | M017 |
| DDM Instant Antiseptic Pain Relief | CAMPHOR 10.8% AND PHENOL 4.7% | Discount Drug Mart | 5d56c74f-604d-4fed-e053-2a91aa0a417c | 2023-12-19 | Warnings | M017 |
| HEB Camphor Phenol | CAMPHOR 10.8% AND PHENOL 4.7% | H E B | 5d573883-001d-e5a4-e053-2991aa0a6203 | 2023-12-18 | Warnings | M017 |
| Petrocort Antipruritic Lip 21 | HYDROCORTISONE | Clinical Formula LLC | 7d408e08-d777-4dfb-bb5e-b4fe5d6f4c7b | 2023-12-15 | Warnings | M017 |
| DermaWound Wound Care Venous Stasis | BENZOCAINE HYDROCHLORIDE | Progressive Doctors, LLC | 6221ba86-8b7f-48c8-8284-6950f9fc36b1 | 2023-12-15 | Warnings | M017 |
| Lidocaine Pain Relief Roll-On | LIDOCAINE 4% | Humco Holding Group, Inc. | a8be9e46-1616-40a9-e053-2a95a90ac3bc | 2023-12-15 | Warnings | M017 |
| Hot/Cold Menthol 16% Roll-On | HOT/COLD MENTHOL 16% ROLL-ON | Humco Holding Group, Inc | a8bf9744-9979-13c1-e053-2a95a90a30aa | 2023-12-15 | Warnings | M017 |
| Freds Medicated anti itch | PRAMOXINE HYDROCHLORIDE, MENTHOL | Discount Drug Mart | 8697b932-da5a-717e-e053-2a91aa0afcae | 2023-12-12 | Warnings | M017 |
| CVS Medicated anti itch | PRAMOXINE HYDROCHLORIDE, MENTHOL | CVS | 86972218-31fe-6942-e053-2991aa0a8850 | 2023-12-12 | Warnings | M017 |
| Best Choice Medicated anti itch | PRAMOXINE HYDROCHLORIDE, MENTHOL | value merchandisers | 869631f8-aa1e-8ea4-e053-2a91aa0a5c57 | 2023-12-12 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE 1% | Weeks & Leo Co., Inc. | 0c5325e3-4796-856c-e063-6394a90a1f90 | 2023-12-12 | Warnings | M017 |
| Westlake Anti-itch | HYDROCORTISONE | Westlake Pharma LLC | 0c53c982-3f23-a2d5-e063-6394a90acd55 | 2023-12-12 | 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 |