Mylanta Gas Minis Assorted Fruit Flavor

Product NDC: 62372-801
11-digit product format: 623720801
Labeler code: 62372
Product ID: 62372-801_0bb22980-478b-bc8c-e063-6394a90a1fee
Type: HUMAN OTC DRUG
Nonproprietary name: Simethicone
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Infirst Healthcare Inc.
Application: M002
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-03-21
Substance: DIMETHICONE
Active strength: 125 mg/1
Pharmacologic classes: Skin Barrier Activity [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.

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 package	package	62372-801	62372-801-03	D	Discontinued by firm		2026-08-03
excluded package	package	62372-801	62372-801-50	D	Discontinued by firm		2026-08-03

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, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	62372-801-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	62372-801-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	62372-801-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	62372-801-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	62372-801-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	62372-801-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	62372-801-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	62372-801-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	62372-801-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	62372-801-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	62372-801-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	62372-801-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	62372-801-50	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	62372-801-03	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	62372-801-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	62372-801-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	62372-801-50	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	62372-801-03	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	62372-801-50	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	62372-801-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	62372-801-50	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	62372-801-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	62372-801-50	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	62372-801-03	`557ba5c1ecfa…`	`9c80585c8c6e…`

Additional Listing Data#

Finished product: Yes
Brand name base: Mylanta Gas Minis Assorted Fruit Flavor
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIMETHICONE	125 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
314221	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
c6db9af2-d457-477d-baa9-470ddbba5905	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
62372-801-03	Mylanta Gas Minis Assorted Fruit Flavor	3 in 1 POUCH	TABLET, CHEWABLE	3	5
62372-801-50	Mylanta Gas Minis Assorted Fruit Flavor	50 in 1 BOTTLE, PLASTIC	TABLET, CHEWABLE	50	5
62372-801-60	Mylanta Gas Minis Assorted Fruit Flavor	60 in 1 BOTTLE, PLASTIC	TABLET, CHEWABLE	60	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62372-801-50	EA - Each	62372-801	adf07469-eb7e-42ed-9a6c-792bc85f7b2a	1	2021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62372-801	MYLANTA GAS MINIS ASSORTED FRUIT FLAVOR (SIMETHICONE) TABLET, CHEWABLE [INFIRST HEALTHCARE INC.]	5	Current NDC, Legacy NDC, 3 package rows	20231220_c6db9af2-d457-477d-baa9-470ddbba5905.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 1 of 13 · 256 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Simethicone	SIMETHICONE	SOFTGEL HEALTHCARE PRIVATE LIMITED	322e6cb3-0ddc-9300-e063-6294a90a972a	2026-07-18	Warnings	Exact identifier application number: M002
Best Choice	SIMETHICONE	BEST CHOICE (VALU MERCHANDISERS COMPANY)	245504a6-d2fc-4e05-871b-bab03f34e154	2026-07-17	Warnings	Exact identifier application number: M002
Best Choice Extra Strength	SIMETHICONE	BEST CHOICE (VALU MERCHANDISERS COMPANY)	a41b2895-abbe-4cf1-9c42-0b5e902d298b	2026-07-17	Warnings	Exact identifier application number: M002
FEVIA Gas Control	SIMETHICONE	VIVUNT PHARMA LLC	4bd53a70-3ba0-364c-e063-6394a90a7a64	2026-07-16	Warnings	Exact identifier application number: M002
FEVIA Gas Control	SIMETHICONE	VIVUNT PHARMA LLC	4b1d1bce-eeef-b790-e063-6294a90a166e	2026-07-16	Warnings	Exact identifier application number: M002
Maximum Strength Antacid Mint	SIMETHICONE	Guardian Drug Company	48ec3132-17cf-1de9-e063-6294a90aa407	2026-07-14	Warnings	Exact identifier application number: M002
Gas Relief	SIMETHICONE	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	cce7f7db-99b8-4d7d-ac77-43da6323ebe1	2026-07-14	Warnings	Exact identifier application number: M002
Gas Relief	SIMETHICONE	Rite Aid Corporation	43e94ffc-a3ec-4a16-98db-b000a6dc4230	2026-07-10	Warnings	Exact identifier application number: M002
Tea Tree Oil Antifungal	TOLNAFTATE	Guangzhou ChuanMa International Trading Co.,Ltd.	55a48fc6-1963-66ea-e063-6294a90a3501	2026-07-02	Warnings	Exact identifier application number: M002
RIGHT REMEDIES Extra Strength Gas Relief	SIMETHICONE	Strive Pharmaceuticals Inc.	2d651784-a17b-12bc-e063-6294a90a8ab2	2026-06-30	Warnings	Exact identifier application number: M002
Gas Relief	GAS RELIEF	Chain Drug Marketing Association, Inc.	912f896b-ff49-40e6-b425-c314e0cbf48e	2026-06-30	Warnings	Exact identifier application number: M002
Gas Relief	SIMETHICONE	Strategic Sourcing Services LLC	0add7687-f9d7-4f70-b9a8-1454db8a7caf	2026-06-29	Warnings	Exact identifier application number: M002
Gas Relief Extra Strength	SIMETHICONE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	447ee411-f4b9-4dd1-a3e0-36ad79bccbf9	2026-06-25	Warnings	Exact identifier application number: M002
Gas Relief	SIMETHICONE	AmerisourceBergen (Good Neighbor Pharmacy) 46122	33bee4db-d4aa-4c72-8eeb-46ff374a92a6	2026-06-10	Warnings	Exact identifier application number: M002
Gas Relief	SIMETHICONE	P & L Development, LLC	f4526eba-e6d0-44de-99ea-4af7a6dba199	2026-06-10	Warnings	Exact identifier application number: M002
SIMETHICONE	SIMETHICONE	YYBA	50250112-933c-ffb1-e063-6394a90aaafb	2026-06-09	Warnings	Exact identifier application number: M002
INFANTS GAS RELIEF	SIMETHICONE	Mollec Inc	53705dbc-daca-2214-e063-6294a90a1097	2026-06-04	Warnings	Exact identifier application number: M002
Childrens Simethicone Drops	CHILDRENS SIMETHICONE DROPS	PAI Holdings, LLC dba PAI Pharma	6e26ffbe-4c5b-4689-99bc-88b39ed40a25	2026-06-04	Warnings	Exact identifier application number: M002
Infants Simethicone Drops	INFANTS SIMETHICONE DROPS	PAI Holdings, LLC dba PAI Pharma	235f458e-c275-4bc1-9c0f-e007c4040649	2026-06-03	Warnings	Exact identifier application number: M002
Gas Relief Extra Strength	SIMETHICONE	Care One (Retail Business Services, LLC.)	5e2b25a0-eddf-4d58-927f-bc72c0a92c88	2026-06-02	Warnings	Exact identifier application number: M002

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
314221	simethicone 125 MG Chewable Tablet	PSN	c6db9af2-d457-477d-baa9-470ddbba5905	5
314221	simethicone 125 MG Chewable Tablet	SCD	c6db9af2-d457-477d-baa9-470ddbba5905	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
62372-801-03	62372080103	3 TABLET, CHEWABLE in 1 POUCH (62372-801-03)	2019-10-04	0000-00-00	No	No	Current
62372-801-50	62372080150	50 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (62372-801-50)	2016-03-21	0000-00-00	No	No	Current
62372-801-60	62372080160	60 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (62372-801-60)	2016-03-21	0000-00-00	No	No	Current