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 10 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Simethicone	SIMETHICONE	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd	346df37d-b0fc-4fa5-8c19-492fed58c239	2024-11-25	Warnings	Exact identifier application number: M002
Extra Strength Gas Relief Cherry	SIMETHICONE	Retail Business Services, LLC.	1e8ed36d-5236-163b-e063-6294a90ad6ec	2024-11-22	Warnings	Exact identifier application number: M002
Simethicone	SIMETHICONE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	0f9639fa-e1d0-460d-bc46-714a01cd9811	2024-11-21	Warnings	Exact identifier application number: M002
Simethicone	SIMETHICONE	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.	852cec3b-6564-46b2-afe5-ecef31424237	2024-11-21	Warnings	Exact identifier application number: M002
Ultra Strength Gas Relief	SIMETHICONE	Walgreen Co.	d33e413d-4add-459f-ba46-c23b49cfcc87	2024-11-21	Warnings	Exact identifier application number: M002
Gas Relief	SIMETHICONE	Walgreen Co.	d87a20d4-dd1d-4897-9321-f81df2cfbcc7	2024-11-21	Warnings	Exact identifier application number: M002
Ultra Strength Gas Relief	SIMETHICONE	Walgreen Co.	b14b647f-d729-47df-879d-ca08a30b995e	2024-11-21	Warnings	Exact identifier application number: M002
Ultra Strength Gas Relief	SIMETHICONE	Wal-Mart Stores Inc	206d57ec-c854-496e-af53-7d8b2a208d85	2024-11-21	Warnings	Exact identifier application number: M002
Simethicone	SIMETHICONE	WALGREEN CO.	4d523979-e3ae-47e8-9092-00fdffc8bb0b	2024-11-21	Warnings	Exact identifier application number: M002
Gas Relief	SIMETHICONE	Wal-Mart Stores Inc	69351cf9-3092-45ca-8b84-83e3737fa8d4	2024-11-21	Warnings	Exact identifier application number: M002
Simethicone	SIMETHICONE	WALMART INC.	79a9e0a3-9199-4397-ab29-b8a9c843cdf8	2024-11-21	Warnings	Exact identifier application number: M002
Maximum Strength Gas Relief	SIMETHICONE	FOODHOLD U.S.A., LLC	c37def6e-bb10-41ba-8bce-b06c09edbe9f	2024-11-21	Warnings	Exact identifier application number: M002
Gas Relief Ultra Strength	SIMETHICONE 180 MG	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	2cfb8132-6de4-457d-880b-c870a38862ad	2024-11-20	Warnings	Exact identifier application number: M002
Gas-Aid	SIMETHICONE	Leosons Overseas Corp	d271bfcb-bf13-4a97-bc03-f1824826f15a	2024-11-19	Warnings	Exact identifier application number: M002
Gas-Aid Drops for infants	SIMETHICONE	Leosons Overseas Corp	06665701-5f1c-4f8f-8775-e0a4a9ef2029	2024-11-19	Warnings	Exact identifier application number: M002
Mag-AL Plus XS	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND DIMETHICONE	PAI Holdings, LLC dba PAI Pharma	db0c47ab-5296-4195-9fa6-2e338b665094	2024-11-12	Warnings	Exact identifier application number: M002
basic care gas relief	SIMETHICONE	Amazon.com Services LLC	ab1681df-aded-4b0c-9124-87196606183b	2024-11-02	Warnings	Exact identifier application number: M002
Good Sense Gas Relief Extra Strength	SIMETHICONE	L. Perrigo Company	6b2d8591-cc58-457e-92b6-c719eee85605	2024-11-02	Warnings	Exact identifier application number: M002
premier value infants gas relief	SIMETHICONE	Chain Drug Consortium	7b887e53-a70a-4f33-9472-e1175b24400a	2024-10-28	Warnings	Exact identifier application number: M002
Premier Value Extra Strength	SIMETHICONE	PHARMACY VALUE ALLIANCE, LLC	df2b1b62-5bd2-4d02-86c2-537b965a8d20	2024-10-28	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