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 |
|---|---|---|---|---|---|---|
| Gaayou Numbing | DIBUCAINE HYDROCHLORIDE 0.5% NUMBING | Jiangxi Yudexi Pharmaceutical Co., LTD | 4c290118-7880-2a98-e063-6294a90a4c03 | 2026-07-21 | Warnings | M017 |
| Professional Therapy MuscleCare Pain Relieving Cold Gel | CAMPHOR, MENTHOL | Active and Innovative | 572792bb-2819-36c3-e063-6394a90aa504 | 2026-07-21 | Warnings | M017 |
| SYLVIRENE NUMBING | LIDOCAINE 4% NUMBING | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a36edc5-5a89-afb5-e063-6294a90a02dd | 2026-07-21 | Warnings | M017 |
| REINREUDE PROVIDES TEMPORARY RELIEF FOR MINOR MUSCLE AND JOINT PAIN | LIDOCAINE 4% PROVIDES TEMPORARY RELIEF FOR MINOR MUSCLE AND JOINT PAIN | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a45c1cb-c5ab-d872-e063-6394a90aab5d | 2026-07-21 | Warnings | M017 |
| SERYNTH Muscle Comfort | ARNICA MONTANA HPUS 7% MUSCLE COMFORT | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a4c10cd-f0c4-8731-e063-6394a90a10a5 | 2026-07-21 | Warnings | M017 |
| DERMFREE MEDICATED LIP | CAMPHOR 2.0% MEDICATED LIP | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a4d62fb-8dfa-404a-e063-6294a90a385d | 2026-07-21 | Warnings | M017 |
| NATUHEAL RELIEF Cream FOR ECZEMA | HYDROCORTISONE ACETATE 1% RELIEF CREAM FOR ECZEMA | Jiangxi Yudexi Pharmaceutical Co., LTD | 4c92fed1-a8b4-bda8-e063-6394a90a8a33 | 2026-07-20 | Warnings | M017 |
| REDCOOL Arnica Bruise | ARNICA MONTANA HPUS 7% ARNICA BRUISE | Jiangxi Zhongletang Pharmaceuticals Co.,Ltd. | 49911392-e55e-1a6b-e063-6394a90a9af0 | 2026-07-20 | Warnings | M017 |
| Vamy HEMORRHOID | LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID | Jiangxi Yudexi Pharmaceutical Co., LTD | 499197aa-f872-3abf-e063-6294a90aeda2 | 2026-07-20 | Warnings | M017 |
| Subleef NUMBING | LIDOCAINE4% NUMBING | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a201a6b-adde-c0a8-e063-6394a90a8285 | 2026-07-20 | Warnings | M017 |
| PUVIDA NUMBING | MENTHOL 5% (W/W) NUMBING | Jiangxi Yudexi Pharmaceutical Co., LTD | 4de4e317-2f4f-e5d6-e063-6394a90a0611 | 2026-07-20 | Warnings | M017 |
| Careland Lidocaine Plus Menthol Pain Relieving Gel Patches | LIDOCAINE, MENTHOL | Planet (Anhui) Pharmaceutical Co., Ltd. | 8b607c03-a98f-445a-a69e-7625a76ac44b | 2026-07-20 | Warnings | M017 |
| Yodo Salil | OINTMENT | Laboratorio Neo Farmaco del Ecuador Neofarmaco Cia. LTDA. | 56812625-7eab-6a25-e063-6294a90a23fe | 2026-07-20 | Warnings | M017 |
| VBBV Numbing | LIDOCAINE | Jiashen International Trade Limited | 5716c36b-6e97-c294-e063-6394a90aaf5c | 2026-07-20 | Warnings | M017 |
| Burn Relief | LIDOCAINE | Premier Brands of America Inc. | 560c29cc-2453-5d14-e063-6394a90a844f | 2026-07-17 | Warnings | M017 |
| 4% Lidocaine Pain Relief Patch | LIDOCAINE 4% | Guangxi Keyun E-commerce Co., Ltd. | 4981e9c3-2a19-aed8-e063-6294a90af216 | 2026-07-17 | Warnings | M017 |
| endurance wipe | BENZOCAINE | Absorption Pharmaceuticals, LLC | 303db1de-94fc-4543-e063-6294a90a01b9 | 2026-07-17 | Warnings | M017 |
| Professional Therapy MuscleCare pain relieving gel Extra Strength | CAMPHOR, MENTHOL | Active and Innovative Inc. | 56d30c33-ef5a-c63d-e063-6294a90acd29 | 2026-07-17 | Warnings | M017 |
| Mineral Ice Extreme Gel Alpine Fresh Scent | MENTHOL | Carlin Consumer Health LLC | 56d3ca3d-21e1-a40a-e063-6294a90a9ff4 | 2026-07-17 | Warnings | M017 |
| DRAVYNOR TOPICAL ANALGESIC HEAT Patch | MENTHOL 24MG CAPSAICIN 16MG TOPICAL ANALGESIC HEAT PATCH | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 56b83ee8-8d86-9436-e063-6294a90a0c25 | 2026-07-16 | 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 |