MINTOX MAXIMUM STRENGTH

Product NDC: 68071-4114
11-digit product format: 680714114
Labeler code: 68071
Product ID: 68071-4114_1a134f90-34cd-3738-e063-6294a90a5eea
Type: HUMAN OTC DRUG
Nonproprietary name: aluminum hydroxide, magnesium hydroxide, dimethicone
Dosage form: SUSPENSION
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: M001
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

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.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-4114-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-4114-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-4114-1	`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 table
Ingredient	Strength
ALUMINUM HYDROXIDE	400 mg/5mL
MAGNESIUM HYDROXIDE	400 mg/5mL
DIMETHICONE	40 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5QB0T2IUN0	Internal UNII lookup
NBZ3QY004S	Internal UNII lookup
92RU3N3Y1O	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
237870	Internal RxNorm lookup
708127	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5b1f4c78-d42e-32c7-e053-2991aa0a1985	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6e3c022f-0786-43f1-8857-edff89d5153f	Product name	1	20260309
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
efd58652-cb8f-4018-91ca-4b0eb2ff729f	Product name	7	20240226
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62	Product name	3	20210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
e7e58cd3-cacb-49df-8d34-1ee335614abb	Product name	1	20150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-06-04	5b1f4c78-d42e-32c7-e053-2991aa0a1985
2023-01-30	5b1f4c78-d42e-32c7-e053-2991aa0a1985
2021-02-12	5b1f4c78-d42e-32c7-e053-2991aa0a1985
2021-01-29	5b1f4c78-d42e-32c7-e053-2991aa0a1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-4114-1	MINTOX MAXIMUM STRENGTH	355 mL in 1 BOTTLE	SUSPENSION	355		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-4114	MINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [NUCARE PHARMACEUTICALS,INC.]	5	Current NDC, Legacy NDC, 1 package rows	20240606_5b1f4c78-d42e-32c7-e053-2991aa0a1985.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.

Matched openFDA labels page 27 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tums Chewy Bites	CALCIUM CARBONATE	Navajo Manufacturing Company Inc.	297d6703-ed4e-10d3-e063-6394a90a9f3a	2024-12-17	Warnings	Exact identifier application number: M001
Calcium Carbonate 10 gr (648 mg) (Antacid)	CALCIUM CARBONATE 10GR (648 MG)	RUGBY LABORATORIES	f21c8cf7-45cb-492b-bf4a-462024a54569	2024-12-17	Warnings	Exact identifier application number: M001
Extra Strength Antacid Tablets, Caseys 4good	CALCIUM CARBONATE 750 MG	Lil' Drug Store Prodsucts, Inc.	026aefd6-bb80-1ffd-e063-6394a90a1262	2024-12-16	Warnings	Exact identifier application number: M001
Foster and Thrive Regular Strength Antacid	CALCIUM CARBONATE	Strategic Sourcing Services LLC	1aeb60fb-eebe-4e54-be1c-4e01f3b7269c	2024-12-13	Warnings	Exact identifier application number: M001
Foster and Thrive Extra Strength Antacid 127AF Extra Strength Antacid Assorted Fruit	CALCIUM CARBONATE	Strategic Sourcing Services LLC	8b2fabf7-4dc6-445a-842c-b28ae081fdc8	2024-12-13	Warnings	Exact identifier application number: M001
Foster and Thrive Regular Strength Antacid Peppermint	CALCIUM CARBONATE	Strategic Sourcing Services LLC	49d1b6c4-432b-44d3-b073-0185dbed7a90	2024-12-12	Warnings	Exact identifier application number: M001
Mylanta Maximum Strength Classic Flavor	ANTACID AND ANTI GAS ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE AND SIMETHICONE	Infirst Healthcare Inc.	56853b20-a2aa-4b19-a428-3dde232114c6	2024-12-11	Warnings	Exact identifier application number: M001
Mylanta New Tonight Soothing Honey Chamomile	CALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONE	Infirst Healthcare Inc.	123f3005-a0a0-4970-94f1-f6d04741078b	2024-12-11	Warnings	Exact identifier application number: M001
GERI-LANTA MAXIMUM STRENGTH	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE	NuCare Pharmaceuticals, Inc.	fd160cfd-9ad4-81c7-e053-6394a90a33f6	2024-12-11	Warnings	Exact identifier application number: M001
Topcare Ultra Strength Antacid Peppermint	CALCIUM CARBONATE	Topco Associates, LLC	fb434059-7b6e-42e0-acfa-db9879f6a4e4	2024-12-11	Warnings	Exact identifier application number: M001
TopCare Ultra Strength Antacid Assorted Fruit	CALCIUM CARBONATE	Topco Associates, LLC	dd038b15-2ecb-4ee2-b356-db6d87c2f01b	2024-12-11	Warnings	Exact identifier application number: M001
Antacid	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE	Retail Business Services, LLC.	74823298-d24a-4ffe-8446-1661305372b2	2024-12-11	Warnings	Exact identifier application number: M001
Extra Strength Antacid Smooth Dissolve Assorted Fruit	CALCIUM CARBONATE	UNITED NATURAL FOODS, INC. DBA UNFI	1b6a48a7-0703-2d3d-e063-6394a90a4641	2024-12-11	Warnings	Exact identifier application number: M001
Careone Regular Strength Calcium Antacid	CALCIUM CARBONATE	Retail Business Services, LLC.	bdd9a64d-777b-45e0-8a9a-6cdc54baf898	2024-12-11	Warnings	Exact identifier application number: M001
Careone Regular Strength calcium Antacid	CALCIUM CARBONATE	Retail Business Services, LLC.	cb6e12cc-4b88-4046-a9fc-2dbe4bca965e	2024-12-11	Warnings	Exact identifier application number: M001
TopCare Ultra Strength Antacid Assorted Berry	CALCIUM CARBONATE	Topco Associates, LLC	c10c56ba-51cf-47f9-80a8-aa188859608f	2024-12-11	Warnings	Exact identifier application number: M001
Antacid	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE	Retail Business Services, LLC.	ce2edc57-e550-4aa9-bbfe-37933913c9eb	2024-12-11	Warnings	Exact identifier application number: M001
GERI-LANTA MAXIMUM STRENGTH	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE	Geri-Care Pharmaceuticals, Corp	b8712a98-30b7-4154-a5bf-0095ef901412	2024-12-09	Warnings	Exact identifier application number: M001
HEARTBURN RELIEF	ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE	GERI-CARE PHARMACEUTICALS, CORP	1f1dbf41-cb87-37d4-e063-6394a90ae294	2024-12-09	Warnings	Exact identifier application number: M001
MAXIMUM STRENGTH Antacid	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE	Geri-Care Pharmaceuticals, Corp	25c93d2a-3c48-ca3a-e063-6294a90a312e	2024-12-09	Warnings	Exact identifier application number: M001

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5QB0T2IUN0	ALUMINUM HYDROXIDE	21645-51-2	ALUMINUM HYDROXIDE
NBZ3QY004S	MAGNESIUM HYDROXIDE	1309-42-8	MAGNESIUM HYDROXIDE
92RU3N3Y1O	DIMETHICONE	9006-65-9	DIMETHICONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
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	5b1f4c78-d42e-32c7-e053-2991aa0a1985	5
708127	Mintox Maximum Strength 400 MG / 400 MG / 40 MG in 5 mL Oral Suspension	PSN	5b1f4c78-d42e-32c7-e053-2991aa0a1985	5
708127	aluminum hydroxide 80 MG/ML / magnesium hydroxide 80 MG/ML / simethicone 8 MG/ML Oral Suspension [Mintox Plus]	SBD	5b1f4c78-d42e-32c7-e053-2991aa0a1985	5
237870	aluminum hydroxide 80 MG/ML / magnesium hydroxide 80 MG/ML / simethicone 8 MG/ML Oral Suspension	SCD	5b1f4c78-d42e-32c7-e053-2991aa0a1985	5
237870	aluminum hydroxide 2400 MG / magnesium hydroxide 2400 MG / dimethicone 240 MG per 30 ML Oral Suspension	SY	5b1f4c78-d42e-32c7-e053-2991aa0a1985	5
237870	aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG per 5 ML Oral Suspension	SY	5b1f4c78-d42e-32c7-e053-2991aa0a1985	5
237870	aluminum hydroxide 800 MG / magnesium hydroxide 800 MG / dimethicone 80 MG per 10 ML Oral Suspension	SY	5b1f4c78-d42e-32c7-e053-2991aa0a1985	5
708127	Mintox (aluminum hydroxide 400 MG / milk of magnesia 400 MG / simethicone 40 MG) per 5 ML Oral Suspension	SY	5b1f4c78-d42e-32c7-e053-2991aa0a1985	5
708127	Mintox Maximum Strength (aluminum hydroxide 80 MG/ML / magnesium hydroxide 80 MG/ML / simethicone 8 MG/ML) Oral Suspension	SY	5b1f4c78-d42e-32c7-e053-2991aa0a1985	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-4114-1	68071411401	355 mL in 1 BOTTLE (68071-4114-1)	355 ml	2017-10-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MINTOX MAXIMUM STRENGTH - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2024-06-04	HUMAN OTC DRUG LABEL	5