Humco Calaclear
- Product NDC
- 0395-0400
- 11-digit product format
- 003950400
- Labeler code
- 0395
- Product ID
- 0395-0400_0c929258-b193-bc2f-e063-6394a90a8e47
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Pramoxine Hydrochloride and Zinc Acetate
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Humco Holding Group, Inc.
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 1998-03-25
- Substance
- PRAMOXINE HYDROCHLORIDE; ZINC ACETATE
- Active strength
- 10; 1 mg/mL; mg/mL
- Pharmacologic classes
- Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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
- Humco Calaclear
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PRAMOXINE HYDROCHLORIDE | 10 mg/mL |
| ZINC ACETATE | 1 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 88AYB867L5 | Internal UNII lookup |
| FM5526K07A | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5fca3a73-6d66-496b-bd33-6e044f9039bc | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f47a510b-6679-4664-b2d6-47b5c4afe7cc | Product name | 4 | 20260217 |
| 030ce964-9b2d-45aa-b5d3-f78ce03ef61c | Product name | 2 | 20250515 |
| 0306390c-dd77-4363-afe0-63c58088b2a1 | Product name | 1 | 20220120 |
| 503ea967-4b9c-48cf-9e87-c7975295849d | Product name | 2 | 20220120 |
| 190f2a5b-bbc8-65c7-fcb0-97891307b917 | Product name | 1 | 20140508 |
| 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 |
|---|---|---|---|---|---|---|
| 0395-0400-96 | Humco Calaclear | 177 mL in 1 BOTTLE, PLASTIC | LOTION | 177 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0395-0400-96 | ML - Milliliter | 0395-0400 | 5d47f9f0-f8d2-4b5e-a5bf-5e5ef8a7de71 | 1 | 2014-04-03 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| CareALL Creamy Petroleum Jelly | PETROLATUM | New World Imports, Inc | e13fea4e-bd6d-425a-aa7e-1d41dc36bf00 | 2025-12-01 | Warnings | M016 |
| CareALL Creamy Cocoa Butter Petroleum Jelly | PETROLATUM | New World Imports, Inc | 9358b8ef-df14-45fc-9bfd-9052577a1f88 | 2025-12-01 | Warnings | M016 |
| CAREALL Zinc Oxide | ZINC OXIDE | New World Imports Inc | aa9ae4d1-4229-4894-9eaf-8588b2867472 | 2025-12-01 | Warnings | M016 |
| CAREALL Petroleum | PETROLATUM | New World Imports, Inc | 47e999de-08bd-4121-b6d0-270cc603b56d | 2025-12-01 | Warnings | M016 |
| HOEGOA Growth Hair Serum | GLYCERIN | Shantou Oralhoe Biotechnology Co., Ltd. | 44b6609f-c58b-b6ac-e063-6394a90a749b | 2025-11-29 | Warnings | M016 |
| OUHOE Micro Darts Tag gone Patch | GLYCERIN | Shantou Ouhoe Technology Co., Ltd. | 33ce447c-facd-35fb-e063-6394a90a1ead | 2025-11-27 | Warnings | M016 |
| OUHOE Herbal Hair Oil | GLYCERIN | Shantou Ouhoe Technology Co., Ltd. | 30c3df30-e0c6-4efa-e063-6294a90ac40a | 2025-11-27 | Warnings | M016 |
| OUHOE Aloe Soothing Sun Cream | GLYCERIN | Shantou Ouhoe Technology Co., Ltd. | 326781e0-55dc-80fc-e063-6394a90a09aa | 2025-11-27 | Warnings | M016 |
| OUHOE Ultra Anti-Acne Control Gel | GLYCERIN | Shantou Ouhoe Technology Co., Ltd. | 3bd1b734-76b0-5264-e063-6294a90a32d0 | 2025-11-27 | Warnings | M016 |
| OUHOE Lipoma Cream | GLYCERIN | Shantou Ouhoe Technology Co., Ltd. | 3cb4aed1-3b13-a62a-e063-6294a90a6c39 | 2025-11-27 | Warnings | M016 |
| OUHOE Para Crescimento | GLYCERIN | Shantou Ouhoe Technology Co., Ltd. | 42fbfcac-29ab-51f7-e063-6394a90a626f | 2025-11-27 | Warnings | M016 |
| OUHOE Biotin With Hydrolyzed Collagen | GLYCERIN | Shantou Ouhoe Technology Co., Ltd. | 43138915-5fe1-6e32-e063-6294a90abefa | 2025-11-27 | Warnings | M016 |
| EELHOE Pain Relief Patch | GLYCERIN | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 3f835843-eb04-6273-e063-6294a90ab2f0 | 2025-11-27 | Warnings | M016 |
| EELHOE Skin Tag Remover | GLYCERIN | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 32922508-74ae-8347-e063-6294a90a6154 | 2025-11-27 | Warnings | M016 |
| EELHOE Bodyacne Removal Cleanser | GLYCERIN | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 3bbebf1d-2e22-1427-e063-6294a90a7999 | 2025-11-27 | Warnings | M016 |
| EELHOE Skin Advanced Mole Remove Serum | GLYCERIN | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 3efd75f9-438a-f811-e063-6394a90a9450 | 2025-11-27 | Warnings | M016 |
| EELHOE Wart Remover | GLYCERIN | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 3127d616-1933-e783-e063-6294a90a52f7 | 2025-11-27 | Warnings | M016 |
| EELHOE Tanning Mist | GLYCERIN | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 32670243-957d-3a95-e063-6394a90a5893 | 2025-11-27 | Warnings | M016 |
| EELHOE Skin Tag Patches | GLYCERIN | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 3ddd3fb0-b824-0cde-e063-6394a90aea6a | 2025-11-27 | Warnings | M016 |
| WART REMOVER | GLYCERIN | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 3fd47677-52c9-6d43-e063-6294a90aa45b | 2025-11-27 | Warnings | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1248193 | CALACLEAR 1 % / 0.1 % Topical Lotion | PSN | 5fca3a73-6d66-496b-bd33-6e044f9039bc | 7 |
| 1234546 | pramoxine HCl 1 % / zinc acetate 0.1 % Topical Lotion | PSN | 5fca3a73-6d66-496b-bd33-6e044f9039bc | 7 |
| 1248193 | pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical Lotion [Calaclear] | SBD | 5fca3a73-6d66-496b-bd33-6e044f9039bc | 7 |
| 1234546 | pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical Lotion | SCD | 5fca3a73-6d66-496b-bd33-6e044f9039bc | 7 |
| 1248193 | Calaclear (pramoxine hydrochloride 1 % / zinc acetate 0.1 % ) Topical Lotion | SY | 5fca3a73-6d66-496b-bd33-6e044f9039bc | 7 |
| 1234546 | pramoxine HCl 1 % / zinc acetate 0.1 % Topical Lotion | SY | 5fca3a73-6d66-496b-bd33-6e044f9039bc | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0395-0400-96 | 00395040096 | 177 mL in 1 BOTTLE, PLASTIC (0395-0400-96) | 177 ml | 1998-03-25 | 0000-00-00 | No | No | Current |