Infants Gas Relief

Product NDC: 17856-5894
11-digit product format: 178565894
Labeler code: 17856
Product ID: 17856-5894_02bce983-fd0b-4992-8889-9d988bdb7133
Type: HUMAN OTC DRUG
Nonproprietary name: Simethicone
Dosage form: SUSPENSION/ DROPS
Route: ORAL
Labeler: Atlantic Biologicals Corps
Application: part356
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2010-12-07
Marketing end: 0000-00-00
Substance: DIMETHICONE
Active strength: 20 mg/.3mL
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	17856-5894		I	Inactivated by FDA	2026-10-15
excluded package	package	17856-5894	17856-5894-1	D	Discontinued by firm	2026-10-15
excluded package	package	17856-5894	17856-5894-2	I	Inactivated by FDA	2026-10-15
excluded package	package	17856-5894	17856-5894-3	I	Inactivated by FDA	2026-10-15
excluded package	package	17856-5894	17856-5894-4	I	Inactivated by FDA	2026-10-15
excluded package	package	17856-5894	17856-5894-6	I	Inactivated by FDA	2026-10-15
excluded package	package	17856-5894	17856-5894-7	I	Inactivated by FDA	2026-10-15

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 2 · 112 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	17856-5894-4	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-5894-2	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-5894-6	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-5894-7	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-5894-3	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-5894-1	D	Discontinued by firm	`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	17856-5894-4	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-5894-2	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-5894-6	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-5894-7	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-5894-3	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-5894-1	D	Discontinued by firm	`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	17856-5894-4	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-5894-2	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-5894-6	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-5894-7	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-5894-3	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-5894-1	D	Discontinued by firm	`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	17856-5894-4	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-5894-2	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-5894-6	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-5894-7	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-5894-3	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-5894-1	D	Discontinued by firm	`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	17856-5894-4	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-5894-2	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-5894-6	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-5894-7	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-5894-3	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-5894-1	D	Discontinued by firm	`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	17856-5894-4	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-5894-2	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-5894-6	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-5894-7	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-5894-3	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-5894-1	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-5894-4	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-5894-2	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-5894-6	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-5894-7	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-5894-3	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-5894-1	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17856-5894-4	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17856-5894-2	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17856-5894-6	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17856-5894-7	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17856-5894-3	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17856-5894-1	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17856-5894-4	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17856-5894-2	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17856-5894-6	I	Inactivated by FDA	`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, Related label table
NDC	Effective	Related label
17856-5894-1	2023-01-30	MAJOR INFANT GAS RELIEF
17856-5894-2	2023-01-30	MAJOR INFANT GAS RELIEF
17856-5894-3	2023-01-30	MAJOR INFANT GAS RELIEF
17856-5894-4	2023-01-30	MAJOR INFANT GAS RELIEF
17856-5894-6	2023-01-30	MAJOR INFANT GAS RELIEF
17856-5894-7	2023-01-30	MAJOR INFANT GAS RELIEF
17856-5894-1	2021-06-30	MAJOR INFANT GAS RELIEF
17856-5894-3	2021-06-30	MAJOR INFANT GAS RELIEF
17856-5894-4	2021-06-30	MAJOR INFANT GAS RELIEF
17856-5894-7	2021-06-30	MAJOR INFANT GAS RELIEF
17856-5894-1	2020-01-31	MAJOR INFANT GAS RELIEF
17856-5894-3	2020-01-31	MAJOR INFANT GAS RELIEF
17856-5894-4	2020-01-31	MAJOR INFANT GAS RELIEF
17856-5894-7	2020-01-31	MAJOR INFANT GAS RELIEF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
17856-5894-1	Infants Gas Relief	10 mL in 1 CUP	SUSPENSION/ DROPS	10	7
17856-5894-2	Infants Gas Relief	120 in 1 BOX, UNIT-DOSE	SUSPENSION/ DROPS	120	7
17856-5894-2	Infants Gas Relief	0.6 mL in 1 SYRINGE	SUSPENSION/ DROPS	0.6	7
17856-5894-3	Infants Gas Relief	.3 mL in 1 SYRINGE	SUSPENSION/ DROPS	.3	7
17856-5894-4	Infants Gas Relief	60 in 1 CASE	SUSPENSION/ DROPS	60	7
17856-5894-4	Infants Gas Relief	1.2 mL in 1 DOSE PACK	SUSPENSION/ DROPS	1.2	7
17856-5894-6	Infants Gas Relief	120 in 1 BOX, UNIT-DOSE	SUSPENSION/ DROPS	120	7
17856-5894-6	Infants Gas Relief	0.6 mL in 1 SYRINGE	SUSPENSION/ DROPS	0.6	7
17856-5894-7	Infants Gas Relief	120 in 1 BOX, UNIT-DOSE	SUSPENSION/ DROPS	120	7
17856-5894-7	Infants Gas Relief	.3 mL in 1 SYRINGE	SUSPENSION/ DROPS	.3	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-5894	INFANTS GAS RELIEF (SIMETHICONE) SUSPENSION/ DROPS [ATLANTIC BIOLOGICALS CORPS]	7	Legacy NDC, 10 package rows	20210701_fa869550-a0a8-4359-8d23-d2d178090549.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
198857	simethicone 20 MG in 0.3 mL Oral Suspension	PSN	fa869550-a0a8-4359-8d23-d2d178090549	7
198857	simethicone 66.7 MG/ML Oral Suspension	SCD	fa869550-a0a8-4359-8d23-d2d178090549	7
198857	simethicone 20 MG per 0.3 ML Oral Suspension	SY	fa869550-a0a8-4359-8d23-d2d178090549	7
198857	simethicone 40 MG per 0.6 ML Oral Suspension	SY	fa869550-a0a8-4359-8d23-d2d178090549	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
17856-5894-1	17856589401	10 mL in 1 CUP	10 ml					Historical
17856-5894-2	17856589402	120 SYRINGE in 1 BOX, UNIT-DOSE (17856-5894-2) > .6 mL in 1 SYRINGE	120 syringe	2021-06-30	0000-00-00	No	No	Current
17856-5894-3	17856589403	.3 mL in 1 SYRINGE (17856-5894-3)		2021-06-30	0000-00-00	No	No	Current
17856-5894-4	17856589404	60 DOSE PACK in 1 CASE (17856-5894-4) > 1.2 mL in 1 DOSE PACK	60 dose pack	2021-06-30	0000-00-00	No	No	Current
17856-5894-6	17856589406	120 SYRINGE in 1 BOX, UNIT-DOSE (17856-5894-6) > .6 mL in 1 SYRINGE	120 syringe	2021-06-30	0000-00-00	No	No	Current
17856-5894-7	17856589407	120 SYRINGE in 1 BOX, UNIT-DOSE (17856-5894-7) > .3 mL in 1 SYRINGE	120 syringe	2021-06-30	0000-00-00	No	No	Current