AquaSoothe
- Product NDC
- 67777-555
- 11-digit product format
- 677770555
- Labeler code
- 67777
- Product ID
- 67777-555_45878c3c-d05e-984c-e063-6294a90a4661
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- AquaSoothe
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Dynarex Corporation
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-12-16
- Substance
- PETROLATUM
- Active strength
- 41 g/100g
- 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
- AquaSoothe
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PETROLATUM | 41 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4T6H12BN9U | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 725145 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 45878c3c-d05d-984c-e063-6294a90a4661 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67777-555-01 | AquaSoothe | 106 g in 1 TUBE | OINTMENT | 106 | 1 | |
| 67777-555-02 | AquaSoothe | 24 in 1 CASE | OINTMENT | 24 | 1 | |
| 67777-555-03 | AquaSoothe | 396.9 g in 1 JAR | OINTMENT | 396.9 | 1 | |
| 67777-555-04 | AquaSoothe | 12 in 1 CASE | OINTMENT | 12 | 1 | |
| 67777-555-05 | AquaSoothe | 0.9 g in 1 PACKET | OINTMENT | 0.9 | 1 | |
| 67777-555-05 | AquaSoothe | 144 in 1 BOX | OINTMENT | 144 | 1 | |
| 67777-555-06 | AquaSoothe | 12 in 1 CASE | OINTMENT | 12 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 67777-555-01 | GM - Gram | 67777-555 | 7d95612f-11fb-4d15-b3a5-0bcfb61cf422 | 1 | 2026-05-22 |
| 67777-555-02 | GM - Gram | 67777-555 | 5367718f-17a0-4c08-a67f-b4cadb13e4b3 | 1 | 2026-05-22 |
| 67777-555-03 | GM - Gram | 67777-555 | d9b396fa-137d-4055-9b67-4a5d73d09622 | 1 | 2026-05-22 |
| 67777-555-04 | GM - Gram | 67777-555 | f2d93837-49d4-4dee-b470-d50af372b323 | 1 | 2026-05-22 |
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 |
|---|---|---|---|---|---|---|
| JAYSUING Hair Treatment Green Ginger | GLYCERIN | Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. | 2e8e70de-a2e0-7a71-e063-6294a90a90b8 | 2025-11-27 | Warnings | M016 |
| JAYSUING Liquid Wart Flat | GLYCERIN | Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. | 3b0c05d1-a00e-97df-e063-6394a90af3d0 | 2025-11-27 | Warnings | M016 |
| JAYSUING 7 Days Nail Fungus Treatment | GLYCERIN | Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. | 2ef424cc-815a-b331-e063-6394a90aae70 | 2025-11-27 | Warnings | M016 |
| JAYSUING Pain Relief Knee Patches | GLYCERIN | Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. | 358a3e81-abb5-0a65-e063-6294a90a3d69 | 2025-11-27 | Warnings | M016 |
| Sandra Plasencia PDRN Rejuvenating Serum | RH-OLIGOPEPTIDE-1 | Guangzhou Meijiao Medical Biotechnology Co., Ltd. | 449634c8-ff99-1387-e063-6294a90aef45 | 2025-11-27 | Warnings | M016 |
| GLUTATHIONE | KOJIC ACIDSKIN LIGHTENING | HANCHOYEANBIOTEC Co.,Ltd. | 2be274be-e6d0-d961-e063-6294a90a2190 | 2025-11-27 | Warnings | M016 |
| XIMONTH Bee Venom Joint Cream | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 33d18888-8d06-da13-e063-6294a90a743c | 2025-11-26 | Warnings | M016 |
| XIMONTH Bee Venom Wart Remover Patch | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 3e6965b6-8f08-db62-e063-6394a90a64c9 | 2025-11-26 | Warnings | M016 |
| XIMONTH GLP-1 Patches | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 3d03cdfd-2e9e-f9a1-e063-6394a90a6a8b | 2025-11-26 | Warnings | M016 |
| XIMONTH Bee Venom Repair | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 37e40cc1-1121-1eee-e063-6294a90aab26 | 2025-11-26 | Warnings | M016 |
| XIMONTH Liquid Wart Corn Callus Remover | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 3a1b872a-2883-0b70-e063-6294a90af9d6 | 2025-11-26 | Warnings | M016 |
| XIMONTH Jimerito Honey For Eyes | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 3aa38704-4d2b-ffaf-e063-6294a90a323e | 2025-11-26 | Warnings | M016 |
| XIMONTH Bee Honey Eye Drops | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 3e69c950-bbbc-5c47-e063-6294a90a070e | 2025-11-26 | Warnings | M016 |
| Boudreauxs | ZINC OXIDE | C.B. Fleet Company, Inc. | 4c7e832e-55f3-4766-98b7-29b17d741a4b | 2025-11-26 | Warnings | M016 |
| Johnsons Baby Care Essentials Gift Set | ZINC OXIDE | Kenvue Brands LLC | 43edc287-57e1-d96e-e063-6294a90ac5a1 | 2025-11-24 | Warnings | M016 |
| Cetaphil Soothing Gel Cream | ALLANTOIN | Galderma Laboratories, L.P. | bab404f0-2f7a-4bac-b053-cbdc81c029b5 | 2025-11-24 | Warnings | M016 |
| health beyond VITAMINS AD | PETROLATUM | Nantong Health & Beyond Hygienic Products Inc. | de87da51-cf92-402c-b60f-5f28d1724124 | 2025-11-23 | Warnings | M016 |
| Medline | WHITE PETROLATUM | Medline Industries, LP | 00766a7b-797e-dd15-e063-6394a90af9ac | 2025-11-20 | Warnings | M016 |
| Itch Eraser Sensitive | SODIUM BICARBONATE | Tender Corporation d/b/a Adventure Ready Brands | 2250525a-45c2-42ea-e063-6394a90ac001 | 2025-11-18 | Warnings | M016 |
| Moisture Barrier Cream | PETROLATUM, ZINC OXIDE | Derma Sciences Canada Inc. | 43e01e22-7872-8e24-e063-6394a90a17ef | 2025-11-18 | Warnings | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 725145 | petrolatum 41 % Topical Ointment | PSN | 45878c3c-d05d-984c-e063-6294a90a4661 | 1 |
| 725145 | petrolatum 0.41 MG/MG Topical Ointment | SCD | 45878c3c-d05d-984c-e063-6294a90a4661 | 1 |
| 725145 | petrolatum 41 % Topical Ointment | SY | 45878c3c-d05d-984c-e063-6294a90a4661 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 67777-555-01 | 67777055501 | 106 g in 1 TUBE | 106 g | Historical | |||
| 67777-555-02 | 67777055502 | 24 TUBE in 1 CASE (67777-555-02) / 106 g in 1 TUBE (67777-555-01) | 24 tube | 2025-12-16 | No | No | Current |
| 67777-555-03 | 67777055503 | 396.9 g in 1 JAR | 396.9 g | Historical | |||
| 67777-555-04 | 67777055504 | 12 JAR in 1 CASE (67777-555-04) / 396.9 g in 1 JAR (67777-555-03) | 12 jar | 2025-12-16 | No | No | Current |
| 67777-555-05 | 67777055505 | 0.9 g in 1 PACKET | 0.9 g | Historical | |||
| 67777-555-06 | 67777055506 | 12 BOX in 1 CASE (67777-555-06) / 144 PACKET in 1 BOX (67777-555-05) / .9 g in 1 PACKET | 12 box | 2025-12-16 | No | No | Current |