Sunmark infants gas relief drops

Product NDC: 49348-577
11-digit product format: 493480577
Labeler code: 49348
Product ID: 49348-577_44bfb19c-57f6-46cc-b9b9-9b007dab6722
Type: HUMAN OTC DRUG
Nonproprietary name: Simethicone
Dosage form: EMULSION
Route: ORAL
Labeler: McKesson
Application: part332
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2003-10-31
Marketing end: 0000-00-00
Substance: DIMETHICONE
Active strength: 20 mg/.3mL
NDC exclude flag: No
Listing certified through: 2019-12-31
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	49348-577		I	Inactivated by FDA		2026-10-12
excluded package	package	49348-577	49348-577-34	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 · 42 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49348-577-34	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49348-577-34	`f5e01cc5f278…`	`a2eaf40c39c3…`
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	49348-577-34	`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	49348-577-34	`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	49348-577-34	`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	49348-577-34	`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	49348-577-34	`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	49348-577-34	`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	49348-577-34	`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	49348-577-34	`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	49348-577-34	`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	49348-577-34	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	49348-577-34	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	49348-577-34	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	49348-577-34	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	49348-577-34	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	49348-577-34	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	49348-577-34	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	49348-577-34	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	49348-577-34	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	49348-577-34	`9bebd1f3094a…`	`5416666fcb17…`

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
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49348-577-34	2020-01-31	C162847	48780-1	9d75b9d0-df3c-f424-e053-dadaa90a57ce	Sunmark gas relief drops infants

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49348-577-34	Sunmark infants gas relief drops	1 in 1 CARTON	EMULSION	1		1
49348-577-34	Sunmark infants gas relief drops	30 mL in 1 BOTTLE, DROPPER	EMULSION	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49348-577-34	ML - Milliliter	49348-577	433aa19d-4b37-48a1-8412-f529df696dfe	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	SUNMARK INFANTS GAS RELIEF DROPS (SIMETHICONE ) EMULSION [MCKESSON]	1
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	SUNMARK INFANTS GAS RELIEF DROPS (SIMETHICONE ) EMULSION [MCKESSON]	1
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	SUNMARK INFANTS GAS RELIEF DROPS (SIMETHICONE ) EMULSION [MCKESSON]	1
D&C RED NO. 22	INACTIVE INGREDIENT	1678RKX8RT	SUNMARK INFANTS GAS RELIEF DROPS (SIMETHICONE ) EMULSION [MCKESSON]	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	SUNMARK INFANTS GAS RELIEF DROPS (SIMETHICONE ) EMULSION [MCKESSON]	1
MAGNESIUM ALUMINUM SILICATE	INACTIVE INGREDIENT	6M3P64V0NC	SUNMARK INFANTS GAS RELIEF DROPS (SIMETHICONE ) EMULSION [MCKESSON]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	SUNMARK INFANTS GAS RELIEF DROPS (SIMETHICONE ) EMULSION [MCKESSON]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	SUNMARK INFANTS GAS RELIEF DROPS (SIMETHICONE ) EMULSION [MCKESSON]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	SUNMARK INFANTS GAS RELIEF DROPS (SIMETHICONE ) EMULSION [MCKESSON]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49348-577	SUNMARK INFANTS GAS RELIEF DROPS (SIMETHICONE ) EMULSION [MCKESSON]	1	Legacy NDC, 2 package rows	20120910_8c2d86d8-2e67-41c2-a4ce-5a3904408a02.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	8c2d86d8-2e67-41c2-a4ce-5a3904408a02	1
198857	simethicone 66.7 MG/ML Oral Suspension	SCD	8c2d86d8-2e67-41c2-a4ce-5a3904408a02	1
198857	simethicone 20 MG per 0.3 ML Oral Suspension	SY	8c2d86d8-2e67-41c2-a4ce-5a3904408a02	1
198857	simethicone 40 MG per 0.6 ML Oral Suspension	SY	8c2d86d8-2e67-41c2-a4ce-5a3904408a02	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
49348-577-34	49348057734	1 in 1 CARTON	Historical