MINTOX MAXIMUM STRENGTH
- Product NDC
- 17856-5725
- 11-digit product format
- 178565725
- Labeler code
- 17856
- Product ID
- 17856-5725_3b3f429e-d2e4-441c-e063-6294a90aaf4d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- aluminum hydroxide, magnesium hydroxide, dimethicone
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- ATLANTIC BIOLOGICALS CORP.
- Application
- M
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2011-02-01
- Substance
- ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE
- Active strength
- 400; 400; 40 mg/5mL; mg/5mL; mg/5mL
- Pharmacologic classes
- Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Skin Barrier Activity [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 17856-5725 | 17856-5725-1 | D | Discontinued by firm | 2026-10-15 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 17856-5725-1 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 17856-5725-1 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 17856-5725-1 | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 17856-5725-3 | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 17856-5725-1 | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 17856-5725-3 | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 17856-5725-1 | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 17856-5725-3 | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 17856-5725-1 | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 17856-5725-3 | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… |
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
- MINTOX MAXIMUM STRENGTH
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ALUMINUM HYDROXIDE | 400 mg/5mL |
| MAGNESIUM HYDROXIDE | 400 mg/5mL |
| DIMETHICONE | 40 mg/5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5QB0T2IUN0 | Internal UNII lookup |
| NBZ3QY004S | Internal UNII lookup |
| 92RU3N3Y1O | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ac6a47e7-972f-4b82-96da-89926d345e9f | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 17856-5725-1 | 2024-07-30 | Mintox Max |
| 17856-5725-3 | 2024-07-30 | Mintox Max |
| 17856-5725-1 | 2023-01-30 | Mintox Max |
| 17856-5725-3 | 2023-01-30 | Mintox Max |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 17856-5725-1 | MINTOX MAXIMUM STRENGTH | 15 mL in 1 CUP | SUSPENSION | 15 | 9 | |
| 17856-5725-3 | MINTOX MAXIMUM STRENGTH | 30 mL in 1 CUP | SUSPENSION | 30 | 9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 17856-5725-3 | ML - Milliliter | 17856-5725 | 450f9c1d-edc9-4c3f-91ab-6b5580bf91bc | 1 | 2014-09-03 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 17856-5725 | MINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [ATLANTIC BIOLOGICALS CORP.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20250524_ac6a47e7-972f-4b82-96da-89926d345e9f.zip |
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 |
|---|---|---|---|---|---|---|
| Menthol Pain Relieving Cream with Menthol 10% | MENTHOL 10% CREAM | ONE2ZEE LIMITED LIABILITY COMPANY | ae09e93f-3988-4477-ae53-b2f3df9769fb | 2025-05-05 | Warnings | M |
| Anua Zero-Cast Moisturizing Finish Sunscreen SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | ENGLEWOOD LAB, INC. | edf07b7f-46fb-4915-b2ea-83d852617f60 | 2025-04-10 | Warnings | M |
| BRONCOCHEM KIDS COLD AND FLU | ACETAMINOPHEN-PHENYLEPHRINE HCL-GUAIFENESIN | LABORATORIO MAGNACHEM INTERNATIONAL SRL | b6559fb9-2dea-49c0-a274-3e77741a0ffd | 2025-03-23 | Warnings | M |
| BRONCOCHEM MAXIMUM COUGH | DEXTROMETHORPHAN HBR-GYAIFENESIN | LABORATORIO MAGNACHEM INTERNATIONAL SRL | deecdb72-4cdb-4d6f-972f-a425a91afa5a | 2025-03-23 | Warnings | M |
| BRONCOCHEM MAXIMUM COUGH NIGHT | DEXTROMETHORPHAN HBR-PYRILAMINE MALEATE | LABORATORIO MAGNACHEM INTERNATIONAL SRL | dffdfa2c-a52e-4606-9b07-c8993e499f09 | 2025-03-23 | Warnings | M |
| BRONCOCHEM EXPECTORANT II | ACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBR-GUAIFENESIN-PHENYLEPHRINE HCL | LABORATORIO MAGNACHEM INTERNATIONAL SRL | 1fb86dcb-6f51-4c29-99ad-a5a9b7b7526a | 2025-03-23 | Warnings | M |
| BRONCOCHEM MAXIMUM COUGH KIDS | DEXTROMETHORPHAN HBR-GUAIFENESIN | LABORATORIO MAGNACHEM INTERNATIONAL SRL | b0fd2f2f-5cc4-4813-8f99-c78fbe898656 | 2025-03-13 | Warnings | M |
| Menthol Pain Relief Gel Patch | MENTHOL PAIN RELIEF GEL PATCH | ONE2ZEE LIMITED LIABILITY COMPANY | eab185d6-2a54-489d-8114-fe8088624ba4 | 2025-03-04 | Warnings | M |
| Lidocaine 4% Pain Relief Gel Patch | LIDOCAINE 4% PAIN RELIEF GEL PATCH | ONE2ZEE LIMITED LIABILITY COMPANY | 8e5a4ef4-b928-44b3-842c-92f1531af75b | 2025-03-03 | Warnings | M |
| gas relief | SIMETHICONE | Strategic Sourcing Services LLC | 23005295-c5f2-4a76-8431-4a9b8d817d4d | 2025-01-03 | Warnings | M |
| Foster and Thrive infants Gas relief | SIMETHICONE | Strategic Sourcing Services LLC | 824c9dff-0a26-4710-a25b-39df631d6fa6 | 2024-12-13 | Warnings | M |
| BRONCOCHEM COLD AND FLU TEA | ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE | LABORATORIO MAGNACHEM INTERNATIONAL SRL | b7d3f54e-59ef-4b85-a88d-b053058dc1f6 | 2024-12-12 | Warnings | M |
| HYSAN PAIN RELIEVER | METHYL SALICYLATE, CAMPHOR (SYNTHETIC) | HYSAN PHARMACEUTICAL CO LTD | bad73234-c204-40a8-8176-45c75ae500c8 | 2024-10-07 | Warnings | M |
| HYSAN ANALGESIC | METHYL SALICYLATE, CAMPHOR (SYNTHETIC) | HYSAN PHARMACEUTICAL CO LTD | 99a13b0a-1d77-479e-ba99-2cfa638de339 | 2024-10-04 | Warnings | M |
| HYSAN HUO LU MEDICATED | METHYL SALICYLATE, CAMPHOR (SYNTHETIC) | HYSAN PHARMACEUTICAL CO LTD | fe9eeaff-fcbf-4287-9f17-bcf1822bf35b | 2024-10-04 | Warnings | M |
| HYSAN HUA TUO MEDICATED | METHYL SALICYLATE | HYSAN PHARMACEUTICAL CO LTD | b84c4d33-5a77-46e0-b04e-32f73967bd1c | 2024-10-04 | Warnings | M |
| HYSAN HUA TUO HUO LU | METHYL SALICYLATE, CAMPHOR (SYNTHETIC) | HYSAN PHARMACEUTICAL CO LTD | cd2288c4-9909-43c1-91da-b15545b09788 | 2024-10-04 | Warnings | M |
| CLARINS - ROLL-ON DEODORANT Aluminum Chlorohydrate - Antiperspirant, Long-lasting Alcohol-free | ALUMINUM CHLOROHYDRATE | Laboratoires Clarins | 412116a1-f9af-4c03-85e0-aad5738dd797 | 2024-08-05 | Warnings | M |
| BRONCOCHEM MAXIMUM COUGH NIGHT | DEXTROMETHORPHAN HBR-PYRILAMINE MALEATE | LABORATORIO MAGNACHEM INTERNATIONAL SRL | 1a3ed214-e09b-4266-b68b-39e7c3127d26 | 2024-04-22 | Warnings | M |
| CLARUS Antifungal | TOLNAFTATE | Clinical Therapeutic Solutions | 835c3c23-fc3c-404e-8e87-5a0176126730 | 2024-02-28 | Warnings | M |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 237870 | aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG in 5 mL Oral Suspension | PSN | ac6a47e7-972f-4b82-96da-89926d345e9f | 9 |
| 708127 | Mintox Maximum Strength 400 MG / 400 MG / 40 MG in 5 mL Oral Suspension | PSN | ac6a47e7-972f-4b82-96da-89926d345e9f | 9 |
| 708127 | aluminum hydroxide 80 MG/ML / magnesium hydroxide 80 MG/ML / simethicone 8 MG/ML Oral Suspension [Mintox Plus] | SBD | ac6a47e7-972f-4b82-96da-89926d345e9f | 9 |
| 237870 | aluminum hydroxide 80 MG/ML / magnesium hydroxide 80 MG/ML / simethicone 8 MG/ML Oral Suspension | SCD | ac6a47e7-972f-4b82-96da-89926d345e9f | 9 |
| 237870 | aluminum hydroxide 2400 MG / magnesium hydroxide 2400 MG / dimethicone 240 MG per 30 ML Oral Suspension | SY | ac6a47e7-972f-4b82-96da-89926d345e9f | 9 |
| 237870 | aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG per 5 ML Oral Suspension | SY | ac6a47e7-972f-4b82-96da-89926d345e9f | 9 |
| 237870 | aluminum hydroxide 800 MG / magnesium hydroxide 800 MG / dimethicone 80 MG per 10 ML Oral Suspension | SY | ac6a47e7-972f-4b82-96da-89926d345e9f | 9 |
| 708127 | Mintox (aluminum hydroxide 400 MG / milk of magnesia 400 MG / simethicone 40 MG) per 5 ML Oral Suspension | SY | ac6a47e7-972f-4b82-96da-89926d345e9f | 9 |
| 708127 | Mintox Maximum Strength (aluminum hydroxide 80 MG/ML / magnesium hydroxide 80 MG/ML / simethicone 8 MG/ML) Oral Suspension | SY | ac6a47e7-972f-4b82-96da-89926d345e9f | 9 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 17856-5725-1 | 17856572501 | 15 mL in 1 CUP (17856-5725-1) | 15 ml | 2021-01-28 | 0000-00-00 | No | No | Current |
| 17856-5725-3 | 17856572503 | 30 mL in 1 CUP (17856-5725-3) | 30 ml | 2021-01-28 | 0000-00-00 | No | No | Current |