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 |
|---|---|---|---|---|---|---|
| Numbsure LIDOCAINE | LIDOCAINE 4% | Hambli Limited | 43a65a12-ef2a-4608-e063-6394a90a82ea | 2026-01-31 | Warnings | M017 |
| Collajoint Lidocaine Pain Relief Gel Patch | LIDOCAINE PAIN RELIEF GEL PATCH | Henan Enokon Medical Instrument Co., Ltd. | 44e27e7f-992f-d194-e063-6294a90a94e4 | 2026-01-31 | Warnings | M017 |
| CAPSAICIN HEAT Patch | CAPSAICIN HEAT PATCH | Henan Enokon Medical Instrument Co., Ltd. | 49ac2045-2c07-af9a-e063-6294a90a052a | 2026-01-31 | Warnings | M017 |
| COLD AND HOT MEDICATED Patch | COLD AND HOT MEDICATED PATCH | Henan Enokon Medical Instrument Co., Ltd. | 49ac6a7b-25d3-6dc4-e063-6394a90a99b6 | 2026-01-31 | Warnings | M017 |
| COLD AND HOT MEDICATED Patch | COLD AND HOT MEDICATED PATCH | Henan Enokon Medical Instrument Co., Ltd. | 49aca763-be2a-cf38-e063-6294a90a092e | 2026-01-31 | Warnings | M017 |
| PAIN RELIEF HOT Patch | PAIN RELIEF HOT PATCH | Henan Enokon Medical Instrument Co., Ltd. | 49ad128a-0f4c-085a-e063-6294a90ac9bb | 2026-01-31 | Warnings | M017 |
| Walgreens Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Walgreen Company | 3557d2e9-714a-4066-aa73-ea9e3363e574 | 2026-01-30 | Warnings | M017 |
| Alveora HEMORRHOID MASTER | LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID MASTER | Jiangxi Yudexi Pharmaceutical Co., LTD | 4996f96a-898e-de01-e063-6394a90a3907 | 2026-01-30 | Warnings | M017 |
| Sunburn Relief | LIDOCAINE HCL 0.5% | Rite Aid Corporation | b67af0c7-1ae8-4494-bb0e-d7f66ebca352 | 2026-01-30 | Warnings, Adverse reactions | M017 |
| Drs Pharmacy PAIN RELIEF MUSCLE ARITHRITIS | CAPSAICIN | OL PHARMA TECH,LLC | 48fdf9dc-05df-866d-e063-6294a90ae03a | 2026-01-30 | Warnings | M017 |
| ROCKTAPE GO Kinesiology Tape and Analgesic | MENTHOL, METHYL SALICYLATE | Implus Footcare, LLC | b779c7d8-dbe6-472f-9282-6cced25cfd2e | 2026-01-29 | Warnings | M017 |
| RockSauce Warming Massage | MENTHOL, METHYL SALICYLATE | Implus Footcare, LLC | de5f7add-1f2b-438a-ac17-753ebb53e697 | 2026-01-29 | Warnings | M017 |
| RockSauce Warming Massage Roll-On | MENTHOL, METHYL SALICYLATE | Implus Footcare, LLC | 5a2d9c3a-67fc-4c1a-b1e8-62a93880397a | 2026-01-29 | Warnings | M017 |
| Analgesic Dr. Collado | MENTHOL, METHYL SALICYLATE | Laboratorios Dr. Collado, S.A | c0dad2db-7c96-49b8-a451-bf8cfa7f798b | 2026-01-29 | Warnings | M017 |
| RockSauce Warming Massage | MENTHOL, METHYL SALICYLATE | Implus Footcare, LLC | 3121c7f7-d7e5-4ca9-9057-03edf9c94c56 | 2026-01-29 | Warnings | M017 |
| Analgesic Gel Dr. Collado Menthol 4 Methyl Salicylate | MENTHOL, METHYL SALICYLATE | Laboratorios Dr. Collado, S.A. | 87c22e6f-3ab0-47c3-94ea-48b3d1a95d9d | 2026-01-29 | Warnings | M017 |
| ProCure Hydrocortisone Cream Plus | HYDROCORTISONE | Rooftop Consumer Health, Inc. | fe334cae-e019-4397-8498-df3c923ae8b5 | 2026-01-29 | Warnings | M017 |
| Red Oil Pain Relief | CAMPHOR (SYNTHETIC), MENTHOL, PHENOL | The Red Oil Company Inc | 1e36579a-72da-46ba-ac72-5960a11c0880 | 2026-01-29 | Warnings | M017 |
| Extra Strength Balm | CAPSICUM, MENTHOL | NATURES FORMULAE HEALTH PRODUCTS LTD. | 498a5e2a-4de0-561c-e063-6394a90ac05c | 2026-01-29 | Warnings | M017 |
| MENTHOL, CAMPHOR | MENTHOL, CAMPHOR | SUNSET POTENT PAIN RELIEF | 45c76956-db3f-3e84-e063-6394a90adce1 | 2026-01-29 | 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 |