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 |
|---|---|---|---|---|---|---|
| HurriCaine One | TOPICAL ANESTHETIC AND ANTISEPTIC | Beutlich Pharmaceuticals LLC | 459cedbd-9b6f-e450-e063-6394a90afb73 | 2025-12-10 | Warnings | M017 |
| AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 3 | NICOTINE TRANSDERMAL PATCHES | PCHEERY LLC | 45811e83-8d0b-bc2a-e063-6294a90adf50 | 2025-12-09 | Warnings | M017 |
| AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 2 | NICOTINE TRANSDERMAL PATCHES | PCHEERY LLC | 4580d7f0-92a9-d0d0-e063-6394a90ac393 | 2025-12-09 | Warnings | M017 |
| LidoGuard | LIDOCAINE HCL | ALAINA HEALTHCARE PRIVATE LIMITED | c339dffe-bc9b-4fae-a50f-8db463d244c1 | 2025-12-09 | Warnings | M017 |
| Capsaicin Cream 0.075% | CAPSAICIN | ALAINA HEALTHCARE PRIVATE LIMITED | 33e861bd-bb92-4aea-9d4d-1b8847c794fd | 2025-12-09 | Warnings | M017 |
| Methyl Salicylate | METHYL SALICYLATE | ALAINA HEALTHCARE PRIVATE LIMITED | e07c5ebc-5497-4c45-acc5-d12e72e98f3f | 2025-12-09 | Warnings | M017 |
| Ultra Strength Pain Relief Balm | CAMPHOR, MENTHOL | ALAINA HEALTHCARE PRIVATE LIMITED | 80779d1f-0c2a-4ae5-9ed7-eb6877f734ba | 2025-12-09 | Warnings | M017 |
| Pain Relief Balm | MENTHOL AND CAMPHOR | ALAINA HEALTHCARE PRIVATE LIMITED | 12d76b8f-4b1d-4f2d-9722-0adb55093cc4 | 2025-12-09 | Warnings | M017 |
| Trojan Extended Pleasure | BENZOCAINE | Church & Dwight Co., Inc. | be731682-4174-649a-e053-2a95a90a3987 | 2025-12-09 | Warnings | M017 |
| Stopain Clinical Continuous | MENTHOL | Troy Manufacturing, Inc. | 65f8d212-0f0e-4893-b6af-bd68bba46443 | 2025-12-09 | Warnings | M017 |
| Pain and Itch Relief 4% Lidocaine | LIDOCAINE | Walgreens | f84e76a9-6af6-4fd1-be4e-efa05728cbfd | 2025-12-09 | Warnings | M017 |
| Capsimide | CAPSAICIN 0.025% TOPICAL PATCH | Sola Pharmaceuticals | e81c2de8-6429-d681-e053-2995a90a36a9 | 2025-12-08 | Warnings | M017 |
| Extra Strength Cold-Hot Medicated Patches | MENTHOL | Cardinal Health, 110 dba LEADER | a2895c03-747c-4220-8052-4f0428062622 | 2025-12-08 | Warnings | M017 |
| Leader PAIN RELIEF PATCHES | LIDOCAINE | Cardinal Health, 110 dba LEADER | 5feae39e-3ab8-4cda-b9e8-dc221aea2417 | 2025-12-08 | Warnings | M017 |
| Pain Relief Patches | CAMPHOR, MENTHOL, METHYL SALICYLATE | Cardinal Health, 110 dba LEADER | f8837b69-8d85-448c-a4b4-be911bca1f6c | 2025-12-08 | Warnings | M017 |
| CAPSAICIN HOT PATCHES | CAPSAICIN | Cardinal Health, 110 dba LEADER | 76e6bc39-643c-4264-8d98-0e4fa7d778e2 | 2025-12-08 | Warnings | M017 |
| Leader PAIN RELIEF PATCHES | LIDOCAINE | Cardinal Health, 110 dba LEADER | 3be6defd-f429-4dc7-8b37-5910705c0b81 | 2025-12-08 | Warnings | M017 |
| 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 |
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 |