DDM Calaclear
- Product NDC
- 53943-400
- 11-digit product format
- 539430400
- Labeler code
- 53943
- Product ID
- 53943-400_0ce5be01-e0bc-7245-e063-6294a90acccf
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Zinc Acetate and Pramoxine Hydrochloride
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Discount Drug Mart
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 1998-03-25
- Substance
- ZINC OXIDE; PRAMOXINE HYDROCHLORIDE
- Active strength
- 80; 10 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
- DDM Calaclear
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZINC OXIDE | 80 mg/mL |
| PRAMOXINE HYDROCHLORIDE | 10 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| SOI2LOH54Z | Internal UNII lookup |
| 88AYB867L5 | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5d536077-b5c6-29b8-e053-2a91aa0a9ae1 | 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 |
|---|---|---|---|---|---|---|
| 53943-400-96 | DDM Calaclear | 177 mL in 1 BOTTLE, PLASTIC | LOTION | 177 | 4 |
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 |
|---|---|---|---|---|---|---|
| Sunmark Phenolated Calamine | CALAMINE AND ZINC OXIDE AND PHENOL | Strategic Sourcing Services LLC | 8e68efc4-4c95-41c0-9fed-32297b1b2edc | 2023-12-19 | Warnings | M016 |
| Calm and Heal Melting Balm | ALLANTOIN | The Honest Company, Inc. | b08a1bd6-986d-9520-e053-2995a90a865e | 2023-12-19 | Warnings | M016 |
| TopCare Calagesic | CALAMINE AND PRAMOXINE HYDROCHLORIDE LOTION | TOPCO ASSOCIATES LLC | 8dced3ea-147b-3d46-e053-2a95a90aa1c0 | 2023-12-18 | Warnings | M016 |
| TopCare Calamine | CALAMINE 8% AND ZINC OXIDE 8% LOTION | TOPCO ASSOCIATES LLC | 8dcf134e-0427-0c43-e053-2995a90a7c26 | 2023-12-18 | Warnings | M016 |
| HEB Calaclear | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | H E B | 5d576794-88d1-484a-e053-2991aa0aa479 | 2023-12-18 | Warnings | M016 |
| Publix Calamine Medicated | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | Publix | 5d6ba4cf-f2cb-0ecb-e053-2991aa0a5673 | 2023-12-18 | Warnings | M016 |
| TopCare Calaclear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION | TOPCO ASSOCIATES LLC | 8dce8817-b905-4064-e053-2995a90a071e | 2023-12-18 | Warnings | M016 |
| Assured Calamine | CALAMINE 8% AND ZINC OXIDE 8% | Greenbriar International | 9d378cc5-9af0-1389-e053-2995a90a0b96 | 2023-12-18 | Warnings | M016 |
| HEB Calagesic | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | H E B | 5d579680-6bcb-1161-e053-2991aa0aead1 | 2023-12-18 | Warnings | M016 |
| Publix Clear Anti-Itch | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | Publix | 5d6b905f-ed30-1ab7-e053-2a91aa0a816b | 2023-12-18 | Warnings | M016 |
| Humco Calaclear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE | Humco Holding Group, Inc. | 5fca3a73-6d66-496b-bd33-6e044f9039bc | 2023-12-15 | Warnings | M016 |
| Calamine Phenolated Topical Suspension | CALAMINE AND ZINC OXIDE AND PHENOL | Humco Holding Group, Inc | a3816729-be2b-4b4f-a609-953576cd2e3b | 2023-12-15 | Warnings | M016 |
| Humco Mineral Oil Light | MINERAL OIL | Humco Holding Group, Inc. | 753f35c3-1420-4817-ba63-b737a9c99a1d | 2023-12-15 | Warnings | M016 |
| Humco Witch Hazel | WITCH HAZEL | Humco Holding Group, Inc. | 3cf07016-a129-49ca-8fad-b67dda5aa009 | 2023-12-15 | Warnings | M016 |
| Rite Aid Calamine | CALAMINE 8% AND ZINC OXIDE 8% | Rite Aid Corporation | 5df71189-9b36-9dee-e053-2a91aa0a9e49 | 2023-12-15 | Warnings | M016 |
| GNP Witch Hazel | WITCH HAZEL | Amerisource Bergen | 45ac839d-215d-4c5f-8ae5-5e111d170061 | 2023-12-14 | Warnings | M016 |
| La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 Skin Protectant | GLYCERIN | L'Oreal USA Products Inc | 32eaaaab-41bd-4efe-a71d-92e3a702c1e5 | 2023-12-11 | Warnings | M016 |
| La Roche Posay Laboratoire Dermatologique Lipikar Eczema Relief | OATMEAL | COSMETIQUE ACTIVE PRODUCTION | e555de17-9b42-4125-a17b-467bc1d179d7 | 2023-12-11 | Warnings | M016 |
| La Roche Posay Laboratoire Dermatologique Lipikar Eczema Soothing Relief | OATMEAL | L'Oreal USA Products Inc | f7b71606-0044-4729-82e8-4514331806a0 | 2023-12-11 | Warnings | M016 |
| La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 | GLYCERIN | Cosmetique Active Production | 01c8a0d5-bcd1-4639-be45-530a226401f0 | 2023-12-11 | Warnings | M016 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53943-400-96 | 53943040096 | 177 mL in 1 BOTTLE, PLASTIC (53943-400-96) | 177 ml | 2017-10-26 | 0000-00-00 | No | No | Current |