Gas Relief

Product NDC: 51013-132
11-digit product format: 510130132
Labeler code: 51013
Product ID: 51013-132_db03b7a1-354b-4ee0-aafa-e0149c1903dc
Type: HUMAN OTC DRUG
Nonproprietary name: Simethicone
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: PuraCap Pharmaceutical LLC
Application: part332
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2016-07-26
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	51013-132		I	Inactivated by FDA		2026-10-12
excluded package	package	51013-132	51013-132-10	I	Inactivated by FDA		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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51013-132-10	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51013-132-10	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51013-132-10	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51013-132-10	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51013-132-10	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51013-132-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51013-132-10	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51013-132-10	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51013-132-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51013-132-10	2025-01-30	C162847	48780-1	2cef2736-7dd8-d83d-e063-dadaa90ab31f	EXTRA STRENGTH GAS RELIEF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51013-132-10	Gas Relief	3 in 1 CARTON	CAPSULE, LIQUID FILLED	3		1
51013-132-10	Gas Relief	10 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	10		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51013-132	GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC]	1	Legacy NDC, 2 package rows	20160726_ce148c8a-ad2b-48b5-bb96-8bb691a48c74.zip

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
198852	simethicone 125 MG Oral Capsule	PSN	ce148c8a-ad2b-48b5-bb96-8bb691a48c74	1
198852	simethicone 125 MG Oral Capsule	SCD	ce148c8a-ad2b-48b5-bb96-8bb691a48c74	1
198852	dimethicone 125 MG Oral Capsule	SY	ce148c8a-ad2b-48b5-bb96-8bb691a48c74	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51013-132-10	51013013210	3 BLISTER PACK in 1 CARTON (51013-132-10) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	3 blister pack	2016-07-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
EXTRA STRENGTH GAS RELIEF	PuraCap Pharmaceutical LLC \| Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.	2016-07-26	HUMAN OTC DRUG LABEL	1