Infants

Product NDC: 17856-1303
11-digit product format: 178561303
Labeler code: 17856
Product ID: 17856-1303_3288018d-5d72-4792-e063-6294a90a2c8c
Type: HUMAN OTC DRUG
Nonproprietary name: Simethicone
Dosage form: SUSPENSION/ DROPS
Route: ORAL
Labeler: ATLANTIC BIOLOGICALS CORP.
Application: M002
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-09-01
Substance: DIMETHICONE
Active strength: 20 mg/.3mL
Pharmacologic classes: Skin Barrier Activity [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 78 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-1303-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-1303-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-1303-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-1303-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-1303-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-1303-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-1303-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-1303-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-1303-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-1303-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-1303-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-1303-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-1303-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-1303-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-1303-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-1303-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-1303-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-1303-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-1303-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-1303-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-1303-4	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-1303-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-1303-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-1303-5	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-1303-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17856-1303-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17856-1303-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17856-1303-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17856-1303-5	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17856-1303-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17856-1303-4	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17856-1303-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17856-1303-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17856-1303-5	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17856-1303-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17856-1303-4	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17856-1303-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17856-1303-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17856-1303-5	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17856-1303-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17856-1303-4	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17856-1303-3	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17856-1303-2	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17856-1303-5	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17856-1303-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17856-1303-4	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17856-1303-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17856-1303-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17856-1303-5	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17856-1303-1	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Infants
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIMETHICONE	20 mg/.3mL

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
198857	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
27fce442-e328-41d2-bab9-87ab21550c04	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
17856-1303-1	2025-04-25	Rugby ® Infants’ Gas Relief Simethicone Drops
17856-1303-2	2025-04-25	Rugby ® Infants’ Gas Relief Simethicone Drops
17856-1303-3	2025-04-25	Rugby ® Infants’ Gas Relief Simethicone Drops
17856-1303-4	2025-04-25	Rugby ® Infants’ Gas Relief Simethicone Drops
17856-1303-5	2025-04-25	Rugby ® Infants’ Gas Relief Simethicone Drops
17856-1303-1	2023-01-30	Rugby ® Infants’ Gas Relief Simethicone Drops
17856-1303-2	2023-01-30	Rugby ® Infants’ Gas Relief Simethicone Drops
17856-1303-3	2023-01-30	Rugby ® Infants’ Gas Relief Simethicone Drops
17856-1303-4	2023-01-30	Rugby ® Infants’ Gas Relief Simethicone Drops
17856-1303-5	2023-01-30	Rugby ® Infants’ Gas Relief Simethicone Drops

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
17856-1303-1	Infants	120 in 1 BOX, UNIT-DOSE	SUSPENSION/ DROPS	120	2
17856-1303-1	Infants	0.3 mL in 1 SYRINGE	SUSPENSION/ DROPS	0.3	2
17856-1303-2	Infants	0.3 mL in 1 SYRINGE	SUSPENSION/ DROPS	0.3	2
17856-1303-2	Infants	120 in 1 BOX, UNIT-DOSE	SUSPENSION/ DROPS	120	2
17856-1303-3	Infants	0.6 mL in 1 SYRINGE	SUSPENSION/ DROPS	0.6	2
17856-1303-3	Infants	120 in 1 BOX, UNIT-DOSE	SUSPENSION/ DROPS	120	2
17856-1303-4	Infants	120 in 1 BOX, UNIT-DOSE	SUSPENSION/ DROPS	120	2
17856-1303-4	Infants	0.6 mL in 1 SYRINGE	SUSPENSION/ DROPS	0.6	2
17856-1303-5	Infants	1.2 mL in 1 SYRINGE	SUSPENSION/ DROPS	1.2	2
17856-1303-5	Infants	60 in 1 BOX, UNIT-DOSE	SUSPENSION/ DROPS	60	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17856-1303-1	EA - Each	17856-1303	b8601f9f-9eb1-4837-a529-b4cf80be384a	1	2025-12-16
17856-1303-2	EA - Each	17856-1303	786ecd51-d680-46a0-bbb9-cd4ef81721b9	1	2022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-1303	INFANTS (SIMETHICONE) SUSPENSION/ DROPS [ATLANTIC BIOLOGICALS CORP.]	2	Current NDC, Legacy NDC, 10 package rows	20250426_27fce442-e328-41d2-bab9-87ab21550c04.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 9 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Simethicone Certified Plus	SIMETHICONE	Advance Pharmaceutical Inc.	d087743f-b82f-2a5c-e053-2995a90abb20	2024-12-26	Warnings	Exact identifier application number: M002
GNP Regular Strength Gas Relief	DIMETHICONE	Amerisource Bergen	7b63b265-e4f2-4103-935c-22d2d89cc5e8	2024-12-26	Warnings	Exact identifier application number: M002
Infants Gas relief	SIMETHICONE	Topco Associates, LLC	fd6a2537-8db2-492d-b045-6404df2fb9c3	2024-12-26	Warnings	Exact identifier application number: M002
Equaline Stomach Relief	BISMUTH SUBSALICYLATE	UNITED NATURAL FOODS, INC. DBA UNFI	5dae8bbe-219b-4aa1-bf7f-6471fa2856d9	2024-12-20	Warnings	Exact identifier application number: M002
GNP Stomach Relief	BISMUTH SUBSALICYLATE 525 MG	Amerisource Bergen	ead13b6b-de37-49f9-b18e-68096651d47e	2024-12-20	Warnings	Exact identifier application number: M002
Infants Gas relief	SIMETHICONE	UNITED NATURAL FOODS, INC. DBA UNFI	a9902ba0-f239-4e66-8d66-7cef39a5fdc3	2024-12-20	Warnings	Exact identifier application number: M002
GNP Pink Bismuth	BISMUTH SUBSALICYLATE	Amerisource Bergen	a6ed50d5-574f-4d6b-be48-e14659338993	2024-12-20	Warnings	Exact identifier application number: M002
WinCo Foods Gas Relief Extra Strength Softgels	SIMETHICONE	WinCo Foods, LLC	a1a19ef7-4a14-4fcb-8917-631d867be0bb	2024-12-18	Warnings	Exact identifier application number: M002
Discount Drugmart Gas Relief Extra Strength Softgels	SIMETHICONE	Discount Drug Mart, Inc	63f3e5f0-10da-4681-a4f1-8ca1eb7e390f	2024-12-18	Warnings	Exact identifier application number: M002
Quality Choice Gas Relief Extra Strength Softgels	SIMETHICONE	Chain Drug Marketing Association	06dfb541-fd1f-4cee-a4a6-44252f1f65a0	2024-12-18	Warnings	Exact identifier application number: M002
Leader Gas relief	SIMETHICONE	CARDINAL HEALTH 110, LLC. DBA LEADER	0163d372-222e-4a8d-a5cb-5a7af9a7068c	2024-12-17	Warnings	Exact identifier application number: M002
Maximum Strength Gas Relief Softgel-60ct	SIMETHICONE	HEB	f65e362a-2f90-428a-b885-eefdad8cae1e	2024-12-16	Warnings	Exact identifier application number: M002
Maximum Strength Gas Relief	SIMETHICONE	Chain Drug Marketing Association, Inc.	e8b2c528-121d-519a-e053-2a95a90a4119	2024-12-16	Warnings	Exact identifier application number: M002
Gas Relief Ultra Strength	DIMETHICONE	TOPCO ASSOCIATES LLC	b9a4c876-722b-4d6c-807f-005ccf5df320	2024-12-14	Warnings	Exact identifier application number: M002
Gas Relief Extra Strength	DIMETHICONE	TOPCO ASSOCIATES LLC	bb1c54d4-3a36-4b77-8659-2e92845d2f0e	2024-12-14	Warnings	Exact identifier application number: M002
Foster and Thrive Extra Strength Gas Relief Cherry	SIMETHICONE	Strategic Sourcing Services LLC	e47374c8-05c1-4874-871b-e83d9b305bd3	2024-12-13	Warnings	Exact identifier application number: M002
Gas-X Extra Strength	SIMETHICONE	Haleon US Holdings LLC	7ce312ca-542b-4bc0-97b5-f65279e1e84c	2024-12-13	Warnings	Exact identifier application number: M002
Antacid Antigas	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE	Retail Business Services, LLC.	c8173d42-f900-4527-aa56-472d1177a9bc	2024-12-11	Warnings	Exact identifier application number: M002
Simethicone	SIMETHICONE	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd	0c9c5fec-ddd4-41a5-8ff9-6b55c376dd36	2024-11-25	Warnings	Exact identifier application number: M002
Simethicone	SIMETHICONE	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.	f7c40b12-11e4-4b85-afb2-0ea33e4f218c	2024-11-25	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
198857	simethicone 20 MG in 0.3 mL Oral Suspension	PSN	27fce442-e328-41d2-bab9-87ab21550c04	2
198857	simethicone 66.7 MG/ML Oral Suspension	SCD	27fce442-e328-41d2-bab9-87ab21550c04	2
198857	simethicone 20 MG per 0.3 ML Oral Suspension	SY	27fce442-e328-41d2-bab9-87ab21550c04	2
198857	simethicone 40 MG per 0.6 ML Oral Suspension	SY	27fce442-e328-41d2-bab9-87ab21550c04	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
17856-1303-1	17856130301	120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1303-1) / .3 mL in 1 SYRINGE	120 syringe	2021-06-30	0000-00-00	No	No	Current
17856-1303-2	17856130302	120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1303-2) / .3 mL in 1 SYRINGE	120 syringe	2021-06-30	0000-00-00	No	No	Current
17856-1303-3	17856130303	120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1303-3) / .6 mL in 1 SYRINGE	120 syringe	2021-06-30	0000-00-00	No	No	Current
17856-1303-4	17856130304	120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1303-4) / .6 mL in 1 SYRINGE	120 syringe	2021-06-30	0000-00-00	No	No	Current
17856-1303-5	17856130305	60 SYRINGE in 1 BOX, UNIT-DOSE (17856-1303-5) / 1.2 mL in 1 SYRINGE	60 syringe	2021-06-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rugby ® Infants’ Gas Relief Simethicone Drops	ATLANTIC BIOLOGICALS CORP. \| Unit Dose Solutions	2025-04-11	HUMAN OTC DRUG LABEL	2