Mi-Acid Gas Relief

Product NDC: 0904-5068
Requested package NDC: 0904-5068-60
11-digit product format: 009045068
Labeler code: 0904
Product ID: 0904-5068_5587b413-d1a1-4f5e-a62b-3b148f6df42f
Type: HUMAN OTC DRUG
Nonproprietary name: Simethicone
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Major Pharmaceuticals
Application: part332
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2011-03-02
Marketing end: 0000-00-00
Substance: DIMETHICONE
Active strength: 80 mg/1
Pharmacologic classes: Skin Barrier Activity [PE]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0904-5068	0904-5068-60	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 · 15 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0904-5068-60	2024-11-13	C162847	48780-1	1030e365-5f79-111a-e063-dadaa90a10e2	Mi-Acid Gas Relief
0904-5068-60	2024-01-30	C162847	48780-1	1030e365-5f79-111a-e063-dadaa90a10e2	Mi-Acid Gas Relief

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-5068-60	EA - Each	0904-5068	6f3055e0-6cdc-44ea-9134-ca80b5c7bb06	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	MI-ACID GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [AIDAREX PHARMACEUTICALS LLC]	1
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	MI-ACID GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]	1
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	MI-ACID GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [AIDAREX PHARMACEUTICALS LLC]	1
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	MI-ACID GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MI-ACID GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MI-ACID GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]	1
DEXTROSE	INACTIVE INGREDIENT	IY9XDZ35W2	MI-ACID GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [AIDAREX PHARMACEUTICALS LLC]	1
DEXTROSE	INACTIVE INGREDIENT	IY9XDZ35W2	MI-ACID GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MI-ACID GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MI-ACID GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	MI-ACID GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [AIDAREX PHARMACEUTICALS LLC]	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	MI-ACID GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	MI-ACID GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [AIDAREX PHARMACEUTICALS LLC]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	MI-ACID GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	MI-ACID GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [AIDAREX PHARMACEUTICALS LLC]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	MI-ACID GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
92RU3N3Y1O	DIMETHICONE	9006-65-9	DIMETHICONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
603288	Mi-Acid Gas Relief 80 MG Chewable Tablet	PSN	1ff12230-d8ec-432c-8162-b27c60aaed63	1
603288	Mi-Acid Gas Relief 80 MG Chewable Tablet	PSN	73d0dece-0f2e-4b8b-9088-9088feaea064	1
314216	simethicone 80 MG Chewable Tablet	PSN	1ff12230-d8ec-432c-8162-b27c60aaed63	1
314216	simethicone 80 MG Chewable Tablet	PSN	73d0dece-0f2e-4b8b-9088-9088feaea064	1
603288	simethicone 80 MG Chewable Tablet [Mi-Acid Gas Relief]	SBD	1ff12230-d8ec-432c-8162-b27c60aaed63	1
603288	simethicone 80 MG Chewable Tablet [Mi-Acid Gas Relief]	SBD	73d0dece-0f2e-4b8b-9088-9088feaea064	1
314216	simethicone 80 MG Chewable Tablet	SCD	1ff12230-d8ec-432c-8162-b27c60aaed63	1
314216	simethicone 80 MG Chewable Tablet	SCD	73d0dece-0f2e-4b8b-9088-9088feaea064	1
603288	Mi-Acid Gas Relief 80 MG Chewable Tablet	SY	1ff12230-d8ec-432c-8162-b27c60aaed63	1
603288	Mi-Acid Gas Relief 80 MG Chewable Tablet	SY	73d0dece-0f2e-4b8b-9088-9088feaea064	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-5068-60	00904506860	100 TABLET, CHEWABLE in 1 BOTTLE (0904-5068-60)	2011-03-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mi-Acid Gas Relief	NuCare Pharmaceuticals,Inc.	2024-06-20	HUMAN OTC DRUG LABEL	3
Mi-Acid Gas Relief	REMEDYREPACK INC.	2022-06-30	HUMAN OTC DRUG LABEL	7
Mi-Acid Gas Relief	Major Pharmaceuticals	2022-01-19	HUMAN OTC DRUG LABEL	8
Mi-Acid Gas Relief	ATLANTIC BIOLOGICALS CORP.	2020-07-22	HUMAN OTC DRUG LABEL	1
Mi-Acid Gas Relief	Aphena Pharma Solutions - Tennessee, LLC	2017-10-30	HUMAN OTC DRUG LABEL	1
Mi-Acid Gas Relief	Aidarex Pharmaceuticals LLC	2014-02-03	HUMAN OTC DRUG LABEL	1