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 |
|---|---|---|---|---|---|---|
| First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Juicy Peach | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | 30b20bd5-3b4f-8cc7-e063-6394a90a9106 | 2025-03-19 | Warnings | M016 |
| First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Fresh Strawberry | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | 30b2744d-fb59-f383-e063-6294a90abd2a | 2025-03-19 | Warnings | M016 |
| Dr. Butler Hemorrhoid and Perineal | MINERAL OIL 59.8%,PETROLATUM 36% | Beyond Health P.A. | d17b6f16-6893-ce0a-e053-2a95a90aa23a | 2025-03-19 | Warnings | M016 |
| Gold Bond Diabetics Medicated Dry Skin Relief Foot Cream | DIMETHICONE, WHITE PETROLATUM | Chattem, Inc. | b951d1cb-b81e-4d7f-9a67-8405daa89667 | 2025-03-19 | Warnings | M016 |
| Gold Bond Eczema Relief Medicated Hand Cream | COLLOIDAL OATMEAL | Chattem, Inc. | 27457bc5-3edc-4c8b-b8a2-eaf09b511cf8 | 2025-03-19 | Warnings | M016 |
| Nicotine Patches | NICOTINE PATCHES | Zhejiang FTA Shengzuozhi Biotechnology Co., LTD | 30a977c3-6862-670e-e063-6294a90aeb2f | 2025-03-18 | Warnings | M016 |
| YVTYVT Copper Peptides Face Serum | COPPER TRIPEPTIDE-1 | Beijing JUNGE Technology Co., Ltd. | 306f2d48-43b8-359a-e063-6394a90a06dc | 2025-03-16 | Boxed warning, Warnings | M016 |
| Dr Talbots Cooling Perineal Pad | WATER, ALOE BARBADENSIS LEAF JUICE, BIOFLAVONOIDS, CALENDULA OFFICINALIS FLOWER EXTRACT, CHAMOMILLA RECUTITA FLOWER EXTRACT, CITRIC ACID, DECYL GLUCOSIDE, GLYCERIN, LACTIC ACID, LEVULINIC ACID, MENTHA PIPERITA (PEPPERMINT) OIL, SODIUM COCOAMPHOACETATE, POTASSIUM SORBATE | Talbot's Pharmaceuticals family Products, LLC. | 242277e2-ff26-ad4e-e063-6394a90ab317 | 2025-03-14 | Warnings | M016 |
| RID Poison Ivy Rash Relief | CALAMINE AND ZINC OXIDE | Oystershell Consumer Health Inc. | 36c3af9a-2646-4427-e063-6394a90a2c5e | 2025-03-13 | Warnings | M016 |
| Aavini Double Layer Brightening Spot Correcting Essence Oil | AAVINI DOUBLE LAYER BRIGHTENING SPOT CORRECTING ESSENCE OIL | Qingyuan Moksha Biotechnology Co., Ltd. | 2ff89a13-3969-2df1-e063-6394a90ac0d3 | 2025-03-10 | Warnings | M016 |
| 5% Signature Numb cream | 5% LIDOCAINE | Shengnan (Guangzhou) Cosmetics Co., LTD | 3008bbeb-abba-5cdb-e063-6294a90ae483 | 2025-03-10 | Warnings | M016 |
| First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Cucumber Melon | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | 2fc4745c-fac9-7861-e063-6294a90a3f14 | 2025-03-07 | Warnings | M016 |
| AD Skin Protectant | AD SKIN PROTECTANT | WellSpring Pharmaceutical Corporation | d26f1312-2e1b-4106-bc48-a336d4e034ad | 2025-03-07 | Warnings | M016 |
| Aveeno Baby Eczema Therapy Nighttime Balm | OATMEAL | Kenvue Brands LLC | 04d90e45-c2ee-4122-b919-a0eb6d11b59a | 2025-03-04 | Warnings | M016 |
| 5% Signature Numb cream | 5% SIGNATURE | Shengnan (Guangzhou) Cosmetics Co., LTD | 2f80abc0-49d8-968d-e063-6294a90a555b | 2025-03-04 | Warnings | M016 |
| First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Vanilla | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | f19b3056-063c-63ec-e053-2995a90a4614 | 2025-03-04 | Warnings | M016 |
| First Aid Beauty FAB Ultra Repair Skin Protectant Peppermint Twist | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | 2770424d-7414-66d4-e063-6394a90ad4b1 | 2025-03-04 | Warnings | M016 |
| Olay Sensitive Soothing Moisturizer Skin Protectant Fragrance-Free | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | 026bb3a1-3e01-1530-e063-6294a90ab1b1 | 2025-03-04 | Warnings | M016 |
| 5% Dr.care Numb cream | LIDOCAINE | Shengnan (Guangzhou) Cosmetics Co., LTD | 2f905d76-ef9c-c844-e063-6394a90a4dc9 | 2025-03-04 | Warnings | M016 |
| Desitin Maximum Strength Zinc Oxide Diaper Rash | ZINC OXIDE | Kenvue Brands LLC | 1590101a-c968-fca5-e063-6394a90a7ccc | 2025-02-28 | 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 |