Sunmark Caldyphen Clear
- Product NDC
- 49348-610
- 11-digit product format
- 493480610
- Labeler code
- 49348
- Product ID
- 49348-610_0ce5bdec-f4fe-73d9-e063-6294a90a6a87
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Zinc Acetate and Pramoxine Hydrochloride
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Strategic Sourcing Services LLC
- 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
- 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
- Sunmark Caldyphen Clear
- Listing expiration
- 2026-12-31
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 |
|---|---|
| 329cd4ef-b699-46ff-a5d6-907f7c327c03 | 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 |
|---|---|---|---|---|---|---|
| 49348-610-36 | Sunmark Caldyphen Clear | 177 mL in 1 BOTTLE, PLASTIC | LOTION | 177 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49348-610-36 | ML - Milliliter | 49348-610 | 00f00bc9-a5c2-4961-afe7-42bc54dd0e24 | 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 |
|---|---|---|---|---|---|---|
| Petroleum Jelly, Lil Drug Store | PETROLATUM JELLY | Lil' Drug Store Products, Inc. | 5862af40-97e2-d792-e063-6394a90a0f1a | 2026-08-06 | Warnings | M016 |
| AOAO RAPID ACNE RELIEF | SALICYLIC ACID,BENZOYL PEROXIDE | Guangzhou Senmai Biotechnology Co.,Ltd. | 586df874-0f71-ed46-e063-6294a90a0a8e | 2026-08-06 | Warnings | M016 |
| Dealmed Vitamins A and D | WHITE PETROLATUM | Dealmed Medical Supplies, LLC. | d6584809-b438-4b2c-ab37-522e0dbef470 | 2026-08-05 | Warnings | M016 |
| Dealmed Vitamins A and D | PETROLATUM | Dealmed Medical Supplies, LLC. | 84afe4ae-f9e8-406f-9fbe-f413975f86eb | 2026-08-05 | Warnings | M016 |
| Petroleum Jelly | PETROLATUM | Walgreens | 1bb250ee-c4b7-4e9f-9d13-46ef9df4a9f5 | 2026-08-04 | Warnings | M016 |
| Nail Treatment Repairing Liquid | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 57b8b3e5-88be-3a91-e063-6294a90a05be | 2026-08-03 | Warnings | M016 |
| PROCURE | ZINC OXIDE | TWIN MED, LLC | e68ae97e-668e-31c2-e053-2995a90ab4d3 | 2026-08-03 | Warnings | M016 |
| PROCURE VITAMIN A AND D Skin Protectant | PETROLATUM | TWIN MED, LLC | bbbca68e-1b65-49b1-a5fa-ed4da55d05e3 | 2026-08-03 | Warnings | M016 |
| procure | PETROLATUM | TWIN MED, LLC | 32520d8f-91ee-47a1-9129-bf0746791f4b | 2026-08-03 | Warnings | M016 |
| ProCure HydroShield | PETROLATUM 44.28% | Twin Med LLC | 3ab7bfb2-bbcf-0822-e063-6294a90af084 | 2026-08-03 | Warnings | M016 |
| 456 Acne Relief Cream | NIACINAMIDE,SALICYLIC ACID,CENTELLA ASIATICA ROOT,COPTIS CHINENSIS ROOT | Guangzhou Senmai Biotechnology Co.,Ltd. | 5830fd36-0613-1980-e063-6294a90adfb7 | 2026-08-03 | Warnings | M016 |
| Crogooe Skin Relief Cream | COLLOIDAL OATMEAL | Guangdong Outeli Biotechnology Co., Ltd. | 57f9b3e8-25d3-2b20-e063-6394a90aaea5 | 2026-08-01 | Warnings | M016 |
| First Aid Beauty Sensitive Skin Bestsellers Kit | COLLOIDAL OATMEAL | JCS Global Distribution, Inc. | 57c3556a-aad3-3e65-e063-6394a90ab689 | 2026-07-29 | Warnings | M016 |
| DERMFREE INSECT BITE RELIEF | SODIUM BICARBONATE 5% INSECT BITE RELIEF | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 5794886c-0d74-9f35-e063-6394a90a27d8 | 2026-07-27 | Warnings | M016 |
| OKeeffes Lip Repair SEAL and HEAL | PETROLATUM | The Gorilla Glue Company/O'Keeffe's Company | 55f66f54-da39-76c7-e063-6394a90aeda9 | 2026-07-27 | Warnings | M016 |
| ATTITUDE Baby Leaves Diaper cream - Unscented | ZINC OXIDE | 9055-7588 Quebec Inc. (Attitude) | 579aa481-f8ec-b263-e063-6394a90a7754 | 2026-07-27 | Warnings | M016 |
| Boo Boo Magic Diaper Rash Creamy | ZINC OXIDE | Alboo Brands LLC | 5114aff8-adde-e610-e063-6294a90a77ea | 2026-07-27 | Warnings | M016 |
| PrevaDRM Vitamin Repair | SKIN PROTECTANT | Sion Brands LLC | 579e4639-a742-1901-e063-6294a90a2d45 | 2026-07-27 | Warnings | M016 |
| Hello Bello Diaper Rash Cream | ZINC OXIDE | Topiderm, Inc. | e158ba31-e159-4624-a490-fe70baaf4a39 | 2026-07-24 | Warnings | M016 |
| Gethorey Vein Target Microneedle Patch | ALLANTOIN 2% VEIN TARGET MICRONEEDLE PATCH | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 57593145-a874-15d9-e063-6294a90a77d9 | 2026-07-24 | Warnings | M016 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 49348-610-36 | 49348061036 | 177 mL in 1 BOTTLE, PLASTIC (49348-610-36) | 177 ml | 2017-12-12 | 0000-00-00 | No | No | Current |