MI-ACID REGULAR STRENGTH

Product NDC: 0904-0004
11-digit product format: 009040004
Labeler code: 0904
Product ID: 0904-0004_d3ad350d-b0fd-21ed-e053-2a95a90a9188
Type: HUMAN OTC DRUG
Nonproprietary name: aluminum hydroxide, magnesium hydroxide, dimethicone
Dosage form: SUSPENSION
Route: ORAL
Labeler: MAJOR Pharmaceuticals Inc.
Application: part331
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2011-02-01
Marketing end: 2022-05-01
Substance: ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE
Active strength: 200 mg/5mL; mg/5mL; mg/5mL
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

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.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0904-0004		D	Discontinued by firm		2026-10-05
excluded package	package	0904-0004	0904-0004-14	D	Discontinued by firm		2026-10-05

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 · 24 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0904-0004-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0904-0004-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0904-0004-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0904-0004-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0904-0004-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0904-0004-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0904-0004-14	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0904-0004-14	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0904-0004-14	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0904-0004-14	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0904-0004-14	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0904-0004-14	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-0004-14	ML - Milliliter	0904-0004	92933069-17e0-477f-85d5-969fbcb5acc2	1	2013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALUMINUM HYDROXIDE	ACTIVE INGREDIENT	5QB0T2IUN0	MI-ACID REGULAR STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [TYA PHARMACEUTICALS]	2
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	MI-ACID REGULAR STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [TYA PHARMACEUTICALS]	2
MAGNESIUM HYDROXIDE	ACTIVE INGREDIENT	NBZ3QY004S	MI-ACID REGULAR STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [TYA PHARMACEUTICALS]	2
ALUMINUM HYDROXIDE	ACTIVE MOIETY	5QB0T2IUN0	MI-ACID REGULAR STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [TYA PHARMACEUTICALS]	2
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	MI-ACID REGULAR STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [TYA PHARMACEUTICALS]	2
HYDROXIDE ION	ACTIVE MOIETY	9159UV381P	MI-ACID REGULAR STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [TYA PHARMACEUTICALS]	2
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	MI-ACID REGULAR STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [TYA PHARMACEUTICALS]	2
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	MI-ACID REGULAR STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [TYA PHARMACEUTICALS]	2
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	MI-ACID REGULAR STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [TYA PHARMACEUTICALS]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MI-ACID REGULAR STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [TYA PHARMACEUTICALS]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	MI-ACID REGULAR STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [TYA PHARMACEUTICALS]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	MI-ACID REGULAR STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [TYA PHARMACEUTICALS]	2
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	MI-ACID REGULAR STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [TYA PHARMACEUTICALS]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	MI-ACID REGULAR STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [TYA PHARMACEUTICALS]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	MI-ACID REGULAR STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [TYA PHARMACEUTICALS]	2
ALUMINUM HYDROXIDE	ACTIVE INGREDIENT	5QB0T2IUN0	MI-ACID REGULAR STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.]	1
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	MI-ACID REGULAR STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.]	1
MAGNESIUM HYDROXIDE	ACTIVE INGREDIENT	NBZ3QY004S	MI-ACID REGULAR STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.]	1
ALUMINUM HYDROXIDE	ACTIVE MOIETY	5QB0T2IUN0	MI-ACID REGULAR STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.]	1
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	MI-ACID REGULAR STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.]	1
HYDROXIDE ION	ACTIVE MOIETY	9159UV381P	MI-ACID REGULAR STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	MI-ACID REGULAR STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.]	1
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	MI-ACID REGULAR STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.]	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	MI-ACID REGULAR STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MI-ACID REGULAR STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	MI-ACID REGULAR STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	MI-ACID REGULAR STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.]	1
SACCHARIN SODIUM DIHYDRATE	INACTIVE INGREDIENT	SB8ZUX40TY	MI-ACID REGULAR STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	MI-ACID REGULAR STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	MI-ACID REGULAR STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.]	1

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
307746	aluminum hydroxide 200 MG / magnesium hydroxide 200 MG / simethicone 20 MG in 5 mL Oral Suspension	PSN	cd711cb3-293b-42f1-a853-ab02d2054e4e	2
210036	Mi-Acid 200 MG / 200 MG / 20 MG in 5 mL Oral Suspension	PSN	cd711cb3-293b-42f1-a853-ab02d2054e4e	2
210036	aluminum hydroxide 40 MG/ML / magnesium hydroxide 40 MG/ML / simethicone 4 MG/ML Oral Suspension [Mi-Acid]	SBD	cd711cb3-293b-42f1-a853-ab02d2054e4e	2
307746	aluminum hydroxide 40 MG/ML / magnesium hydroxide 40 MG/ML / simethicone 4 MG/ML Oral Suspension	SCD	cd711cb3-293b-42f1-a853-ab02d2054e4e	2
307746	aluminum hydroxide 1200 MG / milk of magnesia 1200 MG / dimethicone 120 MG per 30 ML Oral Suspension	SY	cd711cb3-293b-42f1-a853-ab02d2054e4e	2
307746	aluminum hydroxide 200 MG / milk of magnesia 200 MG / dimethicone 20 MG per 5 ML Oral Suspension	SY	cd711cb3-293b-42f1-a853-ab02d2054e4e	2
307746	aluminum hydroxide 400 MG / milk of magnesia 400 MG / dimethicone 40 MG per 10 ML Oral Suspension	SY	cd711cb3-293b-42f1-a853-ab02d2054e4e	2
210036	Mi-Acid (aluminum hydroxide 200 MG / magnesium hydroxide 200 MG / simethicone 20 MG) per 5 ML Oral Suspension	SY	cd711cb3-293b-42f1-a853-ab02d2054e4e	2
210036	Mi-Acid (aluminum hydroxide 40 MG / magnesium hydroxide 40 MG / simethicone 4 MG) per ML Oral Suspension	SY	cd711cb3-293b-42f1-a853-ab02d2054e4e	2
210036	Mi-Acid (aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG) per 10 ML Oral Suspension	SY	cd711cb3-293b-42f1-a853-ab02d2054e4e	2
307746	aluminum hydroxide 200 MG / magnesium hydroxide 200 MG / simethicone 20 MG in 5 mL Oral Suspension	PSN	a17a800a-6baa-4a83-996b-403a9975930b	1
210036	Mi-Acid 200 MG / 200 MG / 20 MG in 5 mL Oral Suspension	PSN	a17a800a-6baa-4a83-996b-403a9975930b	1
210036	aluminum hydroxide 40 MG/ML / magnesium hydroxide 40 MG/ML / simethicone 4 MG/ML Oral Suspension [Mi-Acid]	SBD	a17a800a-6baa-4a83-996b-403a9975930b	1
307746	aluminum hydroxide 40 MG/ML / magnesium hydroxide 40 MG/ML / simethicone 4 MG/ML Oral Suspension	SCD	a17a800a-6baa-4a83-996b-403a9975930b	1
307746	aluminum hydroxide 1200 MG / milk of magnesia 1200 MG / dimethicone 120 MG per 30 ML Oral Suspension	SY	a17a800a-6baa-4a83-996b-403a9975930b	1
307746	aluminum hydroxide 200 MG / milk of magnesia 200 MG / dimethicone 20 MG per 5 ML Oral Suspension	SY	a17a800a-6baa-4a83-996b-403a9975930b	1
307746	aluminum hydroxide 400 MG / milk of magnesia 400 MG / dimethicone 40 MG per 10 ML Oral Suspension	SY	a17a800a-6baa-4a83-996b-403a9975930b	1
210036	Mi-Acid (aluminum hydroxide 200 MG / magnesium hydroxide 200 MG / simethicone 20 MG) per 5 ML Oral Suspension	SY	a17a800a-6baa-4a83-996b-403a9975930b	1
210036	Mi-Acid (aluminum hydroxide 40 MG / magnesium hydroxide 40 MG / simethicone 4 MG) per ML Oral Suspension	SY	a17a800a-6baa-4a83-996b-403a9975930b	1
210036	Mi-Acid (aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG) per 10 ML Oral Suspension	SY	a17a800a-6baa-4a83-996b-403a9975930b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-0004-14	00904000414	355 mL in 1 BOTTLE (0904-0004-14)	355 ml	2011-02-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MAJ MI-ACID REG	MAJOR Pharmaceuticals Inc. \| GCP Laboratories	2021-12-21	HUMAN OTC DRUG LABEL	3
Mi-Acid Regular Strength	Central Texas Community Health Centers	2016-04-19	HUMAN OTC DRUG LABEL	1
MI-ACID REGULAR STRENGTH - TYA Pharmaceuticals	TYA Pharmaceuticals	2013-07-15	HUMAN OTC DRUG LABEL	2