Gas Relief

Product NDC: 55319-487
Requested package NDC: 55319-487-30
11-digit product format: 553190487
Labeler code: 55319
Product ID: 55319-487_5b1f1c71-5a06-4ac1-97ed-baa62e30e487
Type: HUMAN OTC DRUG
Nonproprietary name: SIMETHICONE
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Family Dollar (FAMILY WELLNESS)
Application: part347
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2016-02-29
Marketing end: 0000-00-00
Substance: DIMETHICONE
Active strength: 125 mg/1
NDC exclude flag: No
Listing certified through: 2020-12-31
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	55319-487	55319-487-30	D	Discontinued by firm		2026-10-12

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 · 4 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…`
2022-08-30 03:57 UTC · source 2022-08-29	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
55319-487-30	2023-01-25	Drug Facts
55319-487-50	2023-01-25	Drug Facts
55319-487-30	2022-01-28	Drug Facts
55319-487-50	2022-01-28	Drug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55319-487	GAS RELIEF EXTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)]	6	Legacy NDC	20230126_45e5a1bb-bd75-4c0f-8c7b-ef13fc49acfa.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55319-487-30	55319048730	30 BLISTER PACK in 1 CARTON (55319-487-30) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	30 blister pack	2016-02-29	0000-00-00	No	No	Current