NDC 57237-316-03 - Aluminum Hydroxide, Magnesium Hydroxide and Simethicone
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 57237-316
- Requested NDC
- 57237-316-03
- Package NDCs from labels
- 57237-316-03, 57237-316-31
- Manufacturer
- Rising Pharma Holdings, Inc.
- Effective date
- 2025-07-01
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| ALUMINUM HYDROXIDE - Rising Pharma Holdings, Inc. | Rising Pharma Holdings, Inc. | 2025-07-01 | HUMAN OTC DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57237-316-03 | Aluminum Hydroxide, Magnesium Hydroxide and Simethicone | 30 mL in 1 CUP, UNIT-DOSE | SUSPENSION | 30 | 3 | |
| 57237-316-31 | Aluminum Hydroxide, Magnesium Hydroxide and Simethicone | 100 in 1 BOX, UNIT-DOSE | SUSPENSION | 100 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 57237-316 | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE AND SIMETHICONE (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONE) SUSPENSION [RISING PHARMA HOLDINGS, INC.] | 2 | Current NDC, 2 package rows | 20241019_982129d4-3cbf-4793-a861-d6c8f34bedc3.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57237-316-03 | ML - Milliliter | 57237-316 | 8d8f9c7b-c4d9-42ba-94c4-161057268f04 | 1 | 2023-09-05 |
| 57237-316-31 | ML - Milliliter | 57237-316 | 3cab9d8d-c9b9-4017-9d23-a14f66fe3869 | 1 | 2023-09-05 |
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 |
|---|---|---|---|---|---|---|
| Softlips Vanilla Watermelon | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | 1fbe85a2-4cd7-45bd-85a2-83bbf75c5f97 | 2024-12-17 | Warnings | 92RU3N3Y1O |
| Softlips Marshmallow Ghost | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | 8d55141d-5d6f-4eec-87dc-d3c808cf7a6a | 2024-12-17 | Warnings | 92RU3N3Y1O |
| Softlips Oasis Watermelon Blackberry | DIMETHICONE, OXYBENZONE, OCTINOXATE | The Mentholatum Company | e1213808-4dad-4fd0-871a-04bba094a3cc | 2024-12-17 | Warnings | 92RU3N3Y1O |
| Softlips Peppermint | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | 1a0062f1-fcfc-4d6a-8274-2ebbc5fbdb27 | 2024-12-17 | Warnings | 92RU3N3Y1O |
| Softlips Oasis Pineapple Coconut, Peach Mango, Strawberry Kiwi | DIMETHICONE, OXYBENZONE, OCTINOXATE | The Mentholatum Company | 7c8a4921-ae45-47fb-a64e-c72b1a386d0d | 2024-12-17 | Warnings | 92RU3N3Y1O |
| Mentholatum Medicated Lip Balm Cherry | DIMETHICONE, OCTINOXATE, OCTISALATE | The Mentholatum Company | 6edb132d-bb67-4e6c-8e18-db0305073a71 | 2024-12-17 | Warnings | 92RU3N3Y1O |
| Mentholatum Medicated Lip Balm Original | DIMETHICONE, OCTINOXATE, OCTISALATE | The Mentholatum Company | f84cc3a4-cc9f-4a38-8b7d-cf8d6cd39df1 | 2024-12-17 | Warnings | 92RU3N3Y1O |
| Mentholatum Natural Ice Sport SPF 30 | AVOBENZONE, DIMETHICONE, OCTINOXATE, OCTISALATE | The Mentholatum Company | 57c35631-42d3-4c6c-bcbb-e2de92b45b13 | 2024-12-17 | Warnings | 92RU3N3Y1O |
| Softlips Cherry Cordial, Maple Butter, Frosted Berry | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | bab8447b-58b8-4160-a91e-05f9fd09ed1d | 2024-12-17 | Warnings | 92RU3N3Y1O |
| Leader Gas relief | SIMETHICONE | CARDINAL HEALTH 110, LLC. DBA LEADER | 0163d372-222e-4a8d-a5cb-5a7af9a7068c | 2024-12-17 | Warnings | 92RU3N3Y1O |
| Secura Dimethicone Protectant | DIMETHICONE | Smith & Nephew Medical Ltd | 83f92ac9-4114-4192-926d-be2854a84106 | 2024-12-16 | Warnings | 92RU3N3Y1O |
| Maximum Strength Gas Relief Softgel-60ct | SIMETHICONE | HEB | f65e362a-2f90-428a-b885-eefdad8cae1e | 2024-12-16 | Warnings | 92RU3N3Y1O |
| Maximum Strength Gas Relief | SIMETHICONE | Chain Drug Marketing Association, Inc. | e8b2c528-121d-519a-e053-2a95a90a4119 | 2024-12-16 | Warnings | 92RU3N3Y1O |
| Copperlife Foot | DIMETHICONE 1% | Tommie Copper, Inc. | cb825d2c-6333-3c1f-e053-2995a90a78f3 | 2024-12-15 | Warnings | 92RU3N3Y1O |
| Tommie Copper Foot | DIMETHICONE 1% | Tommie Copper, Inc. | ca3d3374-a3d4-69e5-e053-2995a90a3ece | 2024-12-15 | Warnings | 92RU3N3Y1O |
| Gas Relief Ultra Strength | DIMETHICONE | TOPCO ASSOCIATES LLC | b9a4c876-722b-4d6c-807f-005ccf5df320 | 2024-12-14 | Warnings | 92RU3N3Y1O |
| Gas Relief Extra Strength | DIMETHICONE | TOPCO ASSOCIATES LLC | bb1c54d4-3a36-4b77-8659-2e92845d2f0e | 2024-12-14 | Warnings | 92RU3N3Y1O |
| Mentholatum Natural Ice Cherry | DIMETHICONE, OCTINOXATE, OCTISALATE | The Mentholatum Company | 33f43f14-8e0b-41b1-8ad0-5723d2a7bf19 | 2024-12-13 | Warnings | 92RU3N3Y1O |
| Household Detox | ALLIUM SATIVUM, ALUMINA, ANTIPYRINUM, BENZINUM, BISPHENOL A, CARBOLICUM ACIDUM, CARBONEUM SULPHURATUM, DIETHYLSTILBESTROL, DIOXIN, FOLLICULINUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PARAFFINUM, PETROLEUM, PHENACETINUM, PTELEA TRIFOLIATA, SODIUM CARBOXYMETHYL CELLULOSE, TEFLON | Deseret Biologicals, Inc. | 7f79058a-c35a-429a-be3c-4cff1d657087 | 2024-12-13 | Warnings | K679OBS311 |
| Foster and Thrive Extra Strength Gas Relief Cherry | SIMETHICONE | Strategic Sourcing Services LLC | e47374c8-05c1-4874-871b-e83d9b305bd3 | 2024-12-13 | Warnings | 92RU3N3Y1O |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.