Calamine Plus Pramoxine HCl
- Product NDC
- 56104-100
- 11-digit product format
- 561040100
- Labeler code
- 56104
- Product ID
- 56104-100_42b813fe-1a86-a199-e063-6394a90a1eff
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Calamine Plus No Touch Spray
- Dosage form
- AEROSOL, SPRAY
- Route
- TOPICAL
- Labeler
- Premier Brands of America Inc.
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-05-28
- Substance
- FERRIC OXIDE RED; ZINC OXIDE; PRAMOXINE HYDROCHLORIDE
- Active strength
- 5; 75; 10 mg/g; mg/g; mg/g
- 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 | 5 mg/g |
| ZINC OXIDE | 75 mg/g |
| PRAMOXINE HYDROCHLORIDE | 10 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1K09F3G675 | Internal UNII lookup |
| SOI2LOH54Z | Internal UNII lookup |
| 88AYB867L5 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1544717 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 36481d67-2346-470b-e063-6294a90aae99 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8 | Product name | 1 | 20140508 |
| 9869efd7-d6dd-0665-5b67-53adbe6ef15e | 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 |
|---|---|---|---|---|---|---|
| 56104-100-10 | Calamine Plus Pramoxine HCl | 116 g in 1 CAN | AEROSOL, SPRAY | 116 | 3 |
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 |
|---|---|---|---|---|---|---|
| LenzaPro Flex | LIDOCAINE/MENTHOL | SOLA Pharmaceuticals | ba498f1d-460b-f4e6-e053-2995a90a5755 | 2025-12-08 | Warnings | M017 |
| LidaFlex | LIDOCAINE | SOLA Pharmaceuticals | b9e49529-13b4-1b0b-e053-2995a90adc7a | 2025-12-08 | Warnings | M017 |
| Rugby Menthol Hot Cold Patch | MENTHOL | RUGBY LABORATORIES | c68d29c2-9b56-4994-e053-2a95a90ae60e | 2025-12-08 | Warnings | M017 |
| Neuracin Topical Gel | NEURACIN TOPICAL ANALGESIC GEL | SOLA Pharmaceuticals | c3166926-30c2-2128-e053-2a95a90a0bf2 | 2025-12-08 | Warnings | M017 |
| Triceptin | LIDOCAINE / MENTHOL / METHYL SALICYLATE | SOLA Pharmaceuticals | ef1b98ab-d2db-038c-e053-2995a90a94b4 | 2025-12-08 | Warnings | M017 |
| SynoFlex Patch | SYNOFLEX PATCH | Sola Pharmaceuticals | de2042c4-6c5e-7365-e053-2a95a90ada2a | 2025-12-08 | Warnings | M017 |
| AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 1 | NICOTINE TRANSDERMAL PATCHES | PCHEERY LLC | 457c860b-091d-8350-e063-6294a90a2f98 | 2025-12-08 | Warnings | M017 |
| AY BENDITO HEMP | MENTHOL, CAMPHOR | AY BENDITO INTERNATIONAL, INC | 457c9bd6-2e72-03e5-e063-6394a90a558c | 2025-12-08 | Warnings | M017 |
| AY BENDITO HEMP ROLL-ON | CAMPHOR, MENTHOL | AY BENDITO INTERNATIONAL, INC | 3e552afc-9305-8825-e063-6294a90a1afe | 2025-12-08 | Warnings | M017 |
| AY BENDITO HEMP | CAMPHOR, MENTHOL | AY BENDITO INTERNATIONAL, INC | 457d89aa-4a84-94a6-e063-6294a90a20c0 | 2025-12-08 | Warnings | M017 |
| Gold Bond Medicated Anti-Itch | PRAMOXINE HYDROCHLORIDE, MENTHOL | Gold Bond Co LLC | 4a2bd277-47dd-4ae6-9b4b-e0ae9aad226b | 2025-12-05 | Warnings | M017 |
| Orajel for Cold Sores Double Medicated, Cream | BENZOCAINE AND WHITE PETROLATUM | Church & Dwight Co., Inc. | b8699a40-8464-ca02-e053-2995a90a4260 | 2025-12-05 | Warnings | M017 |
| Thompson Hydrocortisone 1% | HYDROCORTISONE | Thompson | f8740314-7e1f-815e-e053-6294a90a6eae | 2025-12-05 | Warnings | M017 |
| JUST CBD SOOTHING UNSCENTED | LIDOCAINE HCL | Just Brands LLC | 453f44e2-9e5b-8695-e063-6394a90a4389 | 2025-12-05 | Warnings | M017 |
| JUST CBD ROLL-ON COOLING | MENTHOL | Just Brands LLC | 453fa1a7-368c-ae50-e063-6294a90a5507 | 2025-12-05 | Warnings | M017 |
| JUST CBD ROLL-ON WARMING | CAMPHOR | Just Brands LLC | 4540221f-cf9f-9b6a-e063-6294a90adec3 | 2025-12-05 | Warnings | M017 |
| Gold Bond Extra Strength | MENTHOL | Gold Bond Co LLC | 3e84375f-95d3-420c-b222-02a757412592 | 2025-12-04 | Warnings | M017 |
| Alocane Plus | LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE | Quest Products LLC | b3ec09b9-7511-0895-e053-2a95a90a7840 | 2025-12-04 | Warnings | M017 |
| Gold Bond Medicated Pain and Itch Relief | LIDOCAINE HYDROCHLORIDE | Gold Bond Co LLC | d240e9b8-3506-42ab-8a50-05e8d3fac4ff | 2025-12-04 | Warnings | M017 |
| BLT Skin Cream | BENZOCAINE, LIDOCAINE, TETRACAINE | M2B Pharma LLC | 9dc5db9d-9e0a-cd28-e053-2995a90a6bf7 | 2025-12-04 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1544717 | calamine 8 % / pramoxine HCl 1 % Topical Spray | PSN | 36481d67-2346-470b-e063-6294a90aae99 | 3 |
| 1544717 | calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Spray | SCD | 36481d67-2346-470b-e063-6294a90aae99 | 3 |
| 1544717 | calamine 8 % / pramoxine hydrochloride 1 % Topical Spray | SY | 36481d67-2346-470b-e063-6294a90aae99 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 56104-100-10 | 56104010010 | 116 g in 1 CAN (56104-100-10) | 116 g | 2025-05-28 | No | No | Current |