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 |
|---|---|---|---|---|---|---|
| Lidocaine 4% Topical Anesthetic Cream | LIDOCAINE 4% | Oncor Pharmaceuticals | 1baaa669-05af-4024-a0ba-ee3451756f6a | 2026-01-05 | Warnings | M017 |
| TheraCare Pain Relief | MENTHOL | Veridian Healthcare | 6834a6de-4d1d-4e40-945d-ec5c267abd14 | 2026-01-05 | Warnings | M017 |
| TheraCare Lidocaine Pain Relief | LIDOCAINE | Veridian Healthcare | ee8cd550-64ee-432e-98e5-b68083179a3c | 2026-01-05 | Warnings | M017 |
| REGENECARE HA | LIDOCAINE HCL | MPM Medical LLC | 0eee554f-dfe0-433a-9665-8bdb95229888 | 2026-01-05 | Warnings | M017 |
| Pain Relieving Cream | CAMPHOR AND MENTHOL | PAIN WIZARD LIMITED LIABILITY COMPANY | 2647bba1-87f4-3c16-e063-6394a90ae0c9 | 2026-01-05 | Warnings | M017 |
| TheraCare Lidocaine plus Menthol | LIDOCAINE, MENTHOL | Veridian Healthcare | efddd116-d753-425a-9ded-09b8045024e4 | 2026-01-05 | Warnings | M017 |
| TheraCare Original Menthol | MENTHOL | Veridian Healthcare | ea56e4e1-a758-428b-8758-ee31bb00ca82 | 2026-01-05 | Warnings | M017 |
| Mugwort Patch (Cervical spine use) | 2%MENTHOL | YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED | 478e220c-0d35-9ee0-e063-6294a90ab689 | 2026-01-04 | Warnings | M017 |
| Mugwort Patch (Lumbar spine use) | 2%MENTHOL | YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED | 478e4b21-6d81-4cd3-e063-6394a90a18fe | 2026-01-04 | Warnings | M017 |
| Mugwort Patch (Knee use) | 2%MENTHOL | YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED | 478e86d2-3030-91eb-e063-6394a90a4db0 | 2026-01-04 | Warnings | M017 |
| American Safety and First Aid | HYDROCORTISONE ACETATE | Orazen Inc | 4a543f90-d43c-4487-b27e-f43394c6320d | 2026-01-04 | Warnings | M017 |
| Doctor Hoys Pain Relief Gel | MENTHOL, CAMPHOR (SYNTHETIC) | Dynamic Blending Specialists, Inc. | 50123bb9-d5d8-4ba6-ab94-8ed95fe0f5a8 | 2026-01-02 | Warnings | M017 |
| Doctor Hoys Pain Relief Gel Roll-On | MENTHOL, CAMPHOR (SYNTHETIC) | Dynamic Blending Specialists, Inc. | bf47acb2-6c90-4d5c-820b-447cac9305a4 | 2026-01-02 | Warnings | M017 |
| Amino Rip Muscle Pain Relief | LIDOCAINE HCL | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION | 2bed5764-4217-4aa3-9d90-3b5460dcffa3 | 2026-01-02 | Warnings | M017 |
| Menthozen Cream | METHYL SALICYLATE, MENTHOL, CAPSAICIN | Village Pharma LLC | 63bb0283-cfbe-4e9c-8772-73062c0c8d05 | 2026-01-01 | Warnings | M017 |
| Menthozen Hydrogel | MENTHOL, CAPSAICIN | Village Pharma LLC | 4c979a71-7c8f-4dff-abae-bf4cdf8f67b4 | 2026-01-01 | Warnings | M017 |
| Lidozen Gel | LIDOCAINE HYDROCHLORIDE, MENTHOL | Village Pharma LLC | ffb7831f-4ca9-4d73-8303-e9cd90078982 | 2026-01-01 | Warnings | M017 |
| Sting Relief | BENZOCAINE, ISOPROPYL ALCOHOL | Yiwu Ori-Power Medtech Co.,Ltd. | 116ee6dc-9c49-2e11-e063-6394a90a44ed | 2026-01-01 | Warnings | M017 |
| Menthozen | METHYL SALICYLATE, MENTHOL, CAPSAICIN | Village Pharma LLC | 48b1b99e-d0ec-4e5c-b80c-c0d2d87ecb13 | 2026-01-01 | Warnings | M017 |
| NUVALU ICE THERAPY MENTHOL PAIN RELIEVING | MENTHOL | JC SALES | 5adf457e-b4d0-30c8-e063-6294a90a64b9 | 2026-01-01 | 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 |