Calamine Plus Pramoxine HCl
- Product NDC
- 56104-251
- 11-digit product format
- 561040251
- Labeler code
- 56104
- Product ID
- 56104-251_4229a38a-85a1-4153-e063-6294a90a7971
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Calamine Plus Spray
- Dosage form
- AEROSOL, SPRAY
- Route
- TOPICAL
- Labeler
- Premier Brands of America, Inc.
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-12-20
- Substance
- FERRIC OXIDE RED; ZINC OXIDE; PRAMOXINE HYDROCHLORIDE
- Active strength
- .345; 24.16; 2.72 mg/116g; mg/116g; mg/116g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FERRIC OXIDE RED | .345 mg/116g |
| ZINC OXIDE | 24.16 mg/116g |
| PRAMOXINE HYDROCHLORIDE | 2.72 mg/116g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1K09F3G675 | Internal UNII lookup |
| SOI2LOH54Z | Internal UNII lookup |
| 88AYB867L5 | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| d3452573-f91f-f157-e053-2a95a90a1ad8 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| 56104-251-00 | Calamine Plus Pramoxine HCl | 116 g in 1 CANISTER | AEROSOL, SPRAY | 116 | 6 |
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 |
|---|---|---|---|---|---|---|
| 5 Elementum Delay Wipes | BENZOCAINE DELAY WIPES | MSVenturesGroup O | 440539b0-612b-3b41-e063-6294a90a1ddd | 2026-02-05 | Warnings | M017 |
| COOLING PAIN RELIEF | MENTHOL, CAMPHOR | CHEMCO CORPORATION | 4a156400-7001-d00d-e063-6294a90aa714 | 2026-02-05 | Warnings | M017 |
| burnrelief | LIDOCAINE HCL | Publix Super Markets, Inc. | 9660f5e1-d39e-4f86-bf96-dff0f3bb729d | 2026-02-05 | Warnings, Adverse reactions | M017 |
| Aloe Vera Gel | LIDOCAINE HCL, MENTHOL | Publix Super Markets, Inc. | fe442f1e-7045-481a-a501-d629bf568dfb | 2026-02-05 | Warnings, Adverse reactions | M017 |
| Care Lix Pain Relief | SALICYLIC ACID | ACQUIRED B SCALE LLC | 65dffffd-ede1-45e2-aa91-bdd5df2df6a6 | 2026-02-05 | Warnings | M017 |
| 2.5% Menthol PAIN RELIEF | MENTHOL | Nantong Health & Beyond Hygienic Products Inc. | 8075ba60-772c-4d1a-8584-722bb3e539be | 2026-02-05 | Warnings | M017 |
| 4% Menthol PAIN RELIEF | MENTHOL | Nantong Health & Beyond Hygienic Products Inc. | 51ce716e-b9f3-4e64-8c8e-17520d40f192 | 2026-02-05 | Warnings | M017 |
| 2.0% LIDOCAINE BURN | LIDOCAINE HYDROCHLORIDE | Nantong Health & Beyond Hygienic Products Inc. | 2b58058a-f350-4029-b039-117caf1c0373 | 2026-02-05 | Warnings | M017 |
| 4% MENTHOL COLD THERAPY | MENTHOL | Nantong Health & Beyond Hygienic Products Inc. | 7acc7282-ef4f-41ec-b51d-a88dfed79bd7 | 2026-02-05 | Warnings | M017 |
| Cooling Gel | PAIN RELIEF COOLING GEL | NeilMed Pharmaceuticals Inc. | 49fb637b-ecc5-1f9b-e063-6294a90ab41a | 2026-02-04 | Warnings | M017 |
| Medicaine Sting and Bite | BENZOCAINE | Dynarex Corporation | b721607e-e36b-4691-a824-c8f520bd6386 | 2026-02-04 | Warnings | M017 |
| HEATING PAIN RELIEF | METHYL SALICYLATE, MENTHOL | CHEMCO CORPORATION | 4a05f02e-e882-2cb2-e063-6394a90ad328 | 2026-02-04 | Warnings | M017 |
| MENTHOL, CAMPHOR | MENTHOL, CAMPHOR | CHEMCO CORPORATION | 4a065965-43bd-e0e3-e063-6294a90ad76a | 2026-02-04 | Warnings | M017 |
| Menthol plus Camphor Pain Relief | MENTHOL, CAMPHOR | Veridian Healthcare | 4a0969d3-1f06-3ba7-e063-6294a90a8627 | 2026-02-04 | Warnings | M017 |
| Relief Flex | MENTHOL | Beone Co., Ltd. | 49e6f0ef-78fb-26fe-e063-6294a90a6655 | 2026-02-03 | Warnings | M017 |
| NATURULZ ULTIMATE HEALING | CAPSAICIN | I SHAY COSMETICS INC | 436eac74-d07f-d718-e063-6394a90a8660 | 2026-02-03 | Warnings | M017 |
| TheraCare Muscle and Join Pain Relieving Cream | MENTHOL, METHYL SALICYLATE | Veridian Healthcare | 18f9829e-c5f9-4253-e063-6394a90a70c6 | 2026-02-03 | Warnings | M017 |
| HYDROCORTISONE | HYDROCORTISONE | CVS PHARMACY, INC | 8b8cdb26-8e8f-4e95-9d83-d685c90afe01 | 2026-02-02 | Warnings | M017 |
| Muscular Balm | CAPSAICIN MENTHOL METHYL SALICYLATE | Eagle Indo Pharma, PT | 888f88fc-dcaf-93e5-e053-2a95a90a20e1 | 2026-02-02 | Warnings | M017 |
| Wang Prom Green Balm by Wang Prom | WANG PROM WANG PROM GREEN BALM BY VENTURE GO LLC | AMBIENCE FAMILY INC | 4a063898-16a4-695a-e063-6394a90adb93 | 2026-02-02 | Warnings | M017 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 56104-251-00 | 56104025100 | 116 g in 1 CANISTER (56104-251-00) | 116 g | 2021-12-20 | 0000-00-00 | No | No | Current |