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 |
|---|---|---|---|---|---|---|
| Roll Pain Away | CAPSAICIN | PROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA | 547e647b-0205-221c-e063-6294a90a757c | 2026-06-17 | Warnings | M017 |
| Roll Pain Away Lemongrass | CAPSAICIN | PROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA | 547ef5c0-bc31-d83e-e063-6394a90abfa6 | 2026-06-17 | Warnings | M017 |
| Roll Pain Away Lavender | CAPSAICIN | PROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA | 547ef2d9-f5c7-9de1-e063-6394a90a218b | 2026-06-17 | Warnings | M017 |
| Velloryn EXTRA STRENGTH NEUROPATHY | VELLORYN EXTRA STRENGTH NEUROPATHY | GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd | 547f755f-c65c-37ef-e063-6394a90aa220 | 2026-06-17 | Warnings | M017 |
| Neoteric Diabetic Skin Care 4 oz. | DIMETHICONE | RNA PHARMA LLC | 536f4e79-201b-7100-e063-6394a90a4f82 | 2026-06-16 | Warnings | M017 |
| Medi First Extra Strength Itch Relief | DIPHENHYDRAMINE, ZINC ACETATE | Unifirst First Aid Corporation | 54614e5b-8c72-d308-e063-6294a90a405d | 2026-06-16 | Warnings | M017 |
| Blue Ice Analgesic | MENTHOL | Delon Laboratories (1990) Ltd | 184ed488-6e62-40c6-bb71-1d523280fd6b | 2026-06-16 | Warnings | M017 |
| Medi-First Hydrocortisone 1 % Anti-Itch Cream | HYDROCORTISONE | Unifirst First Aid Corporation | 49f04e5d-746d-cbe9-e063-6294a90a7e88 | 2026-06-16 | Warnings | M017 |
| Lidozall Pro | LIDOCAINE HYDROCHLORIDE | V2 Pharma LLC | ecc26ba7-4ff6-43e6-bfb9-91a9cbb509ff | 2026-06-16 | Warnings | M017 |
| Tiger Balm Pain Relieving Cool | CAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORM | Haw Par Healthcare Ltd. | 41590ba1-32bb-4352-97ba-d6a3cc9d0546 | 2026-06-15 | Warnings | M017 |
| HIGH POTENCY PAIN RELIEF | CAPSAICIN | Xiamen Weisiqi Technology Co., Ltd. | 543949a4-86ed-3734-e063-6394a90a24f2 | 2026-06-14 | Warnings | M017 |
| Natucure HEMORRHOID | LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID | Jiangxi Yudexi Pharmaceutical Co., LTD | 49e402ed-d314-e896-e063-6294a90a826b | 2026-06-14 | Warnings | M017 |
| Nieapf NUMBING | LIDOCAINE 4% NUMBING | Jiangxi Yudexi Pharmaceutical Co., LTD | 49e7534f-bccf-4ef4-e063-6294a90aeb7f | 2026-06-14 | Warnings | M017 |
| HEALMUSZ NUMBING | HEALMUSZ NUMBING | Jiangxi Yudexi Pharmaceutical Co., LTD | 49976ff7-49a4-e4ed-e063-6294a90a3f78 | 2026-06-14 | Warnings | M017 |
| HEALMUSZ HEMORRHOID FISSURE | LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID FISSURE | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a342ac0-6a8d-3408-e063-6394a90a9a10 | 2026-06-14 | Warnings | M017 |
| BOTASUN QUIT SMOKING Nicotine | NICOTINE18% MENTHOL 0.3% QUIT SMOKING NICOTINE | Jiangxi Yudexi Pharmaceutical Co., LTD | 4fa00db9-def5-dcfa-e063-6394a90ac8c2 | 2026-06-14 | Warnings | M017 |
| HEALMUSZ NUMBING | MENTHOL 5% NUMBING | Jiangxi Yudexi Pharmaceutical Co., LTD | 4cbb7df5-5771-ce4b-e063-6294a90aab80 | 2026-06-14 | Warnings | M017 |
| HEALMUSZ ECZEMA | HYDROCORTISONE 1% ECZEMA | Jiangxi Yudexi Pharmaceutical Co., LTD | 511e54e0-2abe-fb76-e063-6294a90ada68 | 2026-06-14 | Warnings | M017 |
| Hydrocortisone 1% Anti-ItchCream | HYDROCORTISONE | Acme United Corporation | 5425fc2b-4f25-3e64-e063-6394a90aff49 | 2026-06-13 | Warnings | M017 |
| Icy Hot Pain Relieving Balm | MENTHOL AND METHYL SALICYLATE | Chattem, Inc. | 40c8c02f-fa5f-4e80-81a0-48271fa6f94b | 2026-06-12 | 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 |