ProCure HydroShield
- Product NDC
- 55681-034
- 11-digit product format
- 556810034
- Labeler code
- 55681
- Product ID
- 55681-034_5828d726-ec07-e486-e063-6294a90a0ba1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Petrolatum 44.28%
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Twin Med LLC
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-09-15
- Marketing end
- 2029-03-31
- Substance
- PETROLATUM
- Active strength
- 44.28 g/100g
- NDC exclude flag
- No
- 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
- ProCure HydroShield
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PETROLATUM | 44.28 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4T6H12BN9U | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2609764 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3ab7bfb2-bbcf-0822-e063-6294a90af084 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55681-034-04 | ProCure HydroShield | 106 g in 1 TUBE | OINTMENT | 106 | 2 | |
| 55681-034-16 | ProCure HydroShield | 453 g in 1 JAR | OINTMENT | 453 | 2 |
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 |
|---|---|---|---|---|---|---|
| Premier Value Calaclear | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | Chain Drug Consortium | 5c89e3ac-ca4d-ec3a-e053-2a91aa0a1c0b | 2023-12-20 | Warnings | M016 |
| Best Choice Medicated Calamine | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | Valu Merchandisers, CO. | 5d6c668a-80b4-de18-e053-2991aa0a38fb | 2023-12-20 | Warnings | M016 |
| Premiere Value Calamine | CALAMINE 8% AND ZINC OXIDE 8% | Chain Drug Consortium | 5c8bde5a-591d-085f-e053-2991aa0a56af | 2023-12-20 | Warnings | M016 |
| Best Choice Anti-Itch Clear | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | Valu Merchandisers, CO | 5d6c51b8-47f8-c38b-e053-2991aa0a0f23 | 2023-12-20 | Warnings | M016 |
| Health Care Calamine | CALAMINE 8% AND ZINC OXIDE 8% | Great Lakes Wholesale, Marketing and Sales Inc | 5d8f02fb-0794-8ec2-e053-2991aa0aac63 | 2023-12-20 | Warnings | M016 |
| Harris Teetter Calagesic | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | Harris Tetter, LLC. | 5c7a7418-c973-2869-e053-2991aa0ab4f5 | 2023-12-20 | Warnings | M016 |
| Harris Teeter Calamine | ZINC OXIDE | Harris Teeter, LLC. | 86021cc5-fea7-4363-8fb2-2b0484437fe8 | 2023-12-20 | Warnings | M016 |
| CVS Itch Relief | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE | CVS Pharmacy | c60cfbf2-6788-43dc-b23a-e3433b7f3265 | 2023-12-20 | Warnings | M016 |
| Sunmark Calamine | CALAMINE 8% AND ZINC OXIDE 8% | Strategic Sourcing Services LLC | c7467f21-56cc-43ca-abfa-e62d35c8baa6 | 2023-12-19 | Warnings | M016 |
| Sunmark Witch Hazel | WITCH HAZEL | Strategic Sourcing Services LLC | 08c00c1a-7ec8-4624-9db0-a0e8430cd126 | 2023-12-19 | Warnings | M016 |
| Sunmark Caldyphen Clear | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | Strategic Sourcing Services LLC | 329cd4ef-b699-46ff-a5d6-907f7c327c03 | 2023-12-19 | Warnings | M016 |
| DDM Calaclear | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | Discount Drug Mart | 5d536077-b5c6-29b8-e053-2a91aa0a9ae1 | 2023-12-19 | Warnings | M016 |
| 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 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2609764 | petrolatum 44.3 % Topical Ointment | PSN | 3ab7bfb2-bbcf-0822-e063-6294a90af084 | 2 |
| 2609764 | petrolatum 0.443 MG/MG Topical Ointment | SCD | 3ab7bfb2-bbcf-0822-e063-6294a90af084 | 2 |
| 2609764 | petrolatum 44.28 % Topical Ointment | SY | 3ab7bfb2-bbcf-0822-e063-6294a90af084 | 2 |
| 2609764 | petrolatum 44.3 % Topical Ointment | SY | 3ab7bfb2-bbcf-0822-e063-6294a90af084 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55681-034-04 | 55681003404 | 106 g in 1 TUBE (55681-034-04) | 106 g | 2025-09-15 | 2027-11-27 | No | No | Historical |
| 55681-034-16 | 55681003416 | 453 g in 1 JAR (55681-034-16) | 453 g | 2025-09-15 | 2029-03-31 | No | No | Historical |