Mylicon Infants Gas Relief Original

Product NDC: 62372-630
11-digit product format: 623720630
Labeler code: 62372
Product ID: 62372-630_0bb18b4c-fbe3-8d2a-e063-6394a90a4f5c
Type: HUMAN OTC DRUG
Nonproprietary name: Simethicone
Dosage form: EMULSION
Route: ORAL
Labeler: Infirst Healthcare
Application: M002
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-03-31
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

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: Mylicon Infants Gas Relief Original
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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198857	Internal RxNorm lookup
809376	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
395be942-d883-4bcb-8811-6fe1521d5a92	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
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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
62372-630-15	Mylicon Infants Gas Relief Original	1 in 1 CARTON	EMULSION	1	5
62372-630-15	Mylicon Infants Gas Relief Original	15 mL in 1 BOTTLE, DROPPER	EMULSION	15	5
62372-630-30	Mylicon Infants Gas Relief Original	30 mL in 1 BOTTLE, DROPPER	EMULSION	30	5
62372-630-30	Mylicon Infants Gas Relief Original	1 in 1 CARTON	EMULSION	1	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62372-630-15	ML - Milliliter	62372-630	97aa3541-8331-4428-a14b-bfb2273cacde	1	2020-04-20
62372-630-30	ML - Milliliter	62372-630	0847b805-d89b-4932-8302-166975f4c655	1	2021-10-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	MYLICON INFANTS GAS RELIEF ORIGINAL (SIMETHICONE) EMULSION [INFIRST HEALTHCARE]	1
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	MYLICON INFANTS GAS RELIEF ORIGINAL (SIMETHICONE) EMULSION [INFIRST HEALTHCARE]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	MYLICON INFANTS GAS RELIEF ORIGINAL (SIMETHICONE) EMULSION [INFIRST HEALTHCARE]	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	MYLICON INFANTS GAS RELIEF ORIGINAL (SIMETHICONE) EMULSION [INFIRST HEALTHCARE]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MYLICON INFANTS GAS RELIEF ORIGINAL (SIMETHICONE) EMULSION [INFIRST HEALTHCARE]	1
D&C RED NO. 22	INACTIVE INGREDIENT	1678RKX8RT	MYLICON INFANTS GAS RELIEF ORIGINAL (SIMETHICONE) EMULSION [INFIRST HEALTHCARE]	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	MYLICON INFANTS GAS RELIEF ORIGINAL (SIMETHICONE) EMULSION [INFIRST HEALTHCARE]	1
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	MYLICON INFANTS GAS RELIEF ORIGINAL (SIMETHICONE) EMULSION [INFIRST HEALTHCARE]	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	MYLICON INFANTS GAS RELIEF ORIGINAL (SIMETHICONE) EMULSION [INFIRST HEALTHCARE]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	MYLICON INFANTS GAS RELIEF ORIGINAL (SIMETHICONE) EMULSION [INFIRST HEALTHCARE]	1
SORBITAN MONOSTEARATE	INACTIVE INGREDIENT	NVZ4I0H58X	MYLICON INFANTS GAS RELIEF ORIGINAL (SIMETHICONE) EMULSION [INFIRST HEALTHCARE]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	MYLICON INFANTS GAS RELIEF ORIGINAL (SIMETHICONE) EMULSION [INFIRST HEALTHCARE]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	MYLICON INFANTS GAS RELIEF ORIGINAL (SIMETHICONE) EMULSION [INFIRST HEALTHCARE]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	MYLICON INFANTS GAS RELIEF ORIGINAL (SIMETHICONE) EMULSION [INFIRST HEALTHCARE]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62372-630	MYLICON INFANTS GAS RELIEF ORIGINAL (SIMETHICONE) EMULSION [INFIRST HEALTHCARE]	5	Current NDC, Legacy NDC, 4 package rows	20240111_395be942-d883-4bcb-8811-6fe1521d5a92.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 4 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gas Relief Extra Strength	SIMETHICONE	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	ea6e04dd-4f57-4a88-b269-af38732915b3	2026-03-19	Warnings	Exact identifier application number: M002
SIMETHICONE INFANT Gas Relief Drops	SIMETHICONE	Atlantic Biologicals Corp.	4d658287-358f-d358-e063-6294a90a4bd3	2026-03-19	Warnings	Exact identifier application number: M002
SIMETHICONE INFANT Gas Relief Drops	SIMETHICONE	Atlantic Biologicals Corp.	410d80fc-e55b-08d0-e063-6294a90aba73	2026-03-18	Warnings	Exact identifier application number: M002
Gas Relief Extra Strength	SIMETHICONE	Walgreens	afcabb34-4ef4-4938-860f-154c204fcd48	2026-03-10	Warnings	Exact identifier application number: M002
Gas Relief	SIMETHICONE 125 MG	Pioneer Life Sciences, LLC	2c7bac92-4596-40aa-a2f2-4ebe380f1f2f	2026-03-10	Warnings	Exact identifier application number: M002
Gas Relief	SIMETHICONE 125 MG	Pioneer Life Sciences, LLC	51dc6493-2f9f-4148-be7d-abfef1b25112	2026-03-10	Warnings	Exact identifier application number: M002
Gas Relief Extra Strength	SIMETHICONE	TOP CARE (Topco Associates LLC)	ed8a723a-7dac-4670-8f02-f4154e0a36c9	2026-03-02	Warnings	Exact identifier application number: M002
Extra Strength Gas Relief	SIMETHICONE	Shield Pharmaceuticals Corp	fafb57da-0682-475e-8ff9-17f2182129ef	2026-02-24	Warnings	Exact identifier application number: M002
Gas Relief	SIMETHICONE 180 MG	Pioneer Life Sciences, LLC	f5284b68-f167-41d4-8b2f-ae7bafae0f4c	2026-02-13	Warnings	Exact identifier application number: M002
SFEIXE ANTIFUNGAL PEN	UNDECYLENIC ACID	Zhejiang JOOZENA Medical Technology Co., Ltd.	455ad304-86bc-0abe-e063-6294a90a5b43	2026-02-12	Warnings	Exact identifier application number: M002
Gas Relief Ultimate Strength Softgels	SIMETHICONE	Advanced Rx LLC	5d412711-efd3-4b27-bfde-6fee2f460f8b	2026-02-01	Warnings	Exact identifier application number: M002
QUITA COLICOS Gas RELIEF Drops	SIMETHICONE	DLC Laboratories, Inc.	d4b0fa36-5925-4a6f-b3c9-0c785503976f	2026-01-07	Warnings	Exact identifier application number: M002
Gas Relief	SIMETHICONE	Safeway, Inc.	7ecfe412-6a58-4dff-a52e-2e02a03426f9	2026-01-05	Warnings	Exact identifier application number: M002
Simethicone 180 MG	SIMETHICONE 180 MG	Farmacias De Similares TX LLC	4b2166f7-8d98-dd76-e063-6394a90a7f0f	2026-01-01	Warnings	Exact identifier application number: M002
Target Gas Relief Chews Mixed Berry and Strawberry	SIMETHICONE	Target	11fd2ccd-3a2b-c141-e063-6394a90ab34f	2025-12-20	Warnings	Exact identifier application number: M002
Gas Relief Simethicone 125mg Softgel	SIMETHICONE	NUVICARE LLC	b774c8e6-e68e-4a13-834d-7eba34c5c3e0	2025-12-19	Warnings	Exact identifier application number: M002
Gas Relief Simethicone 180mg Softgel	SIMETHICONE	NUVICARE LLC	51484644-eb45-4282-91c6-289169bcbaf6	2025-12-19	Warnings	Exact identifier application number: M002
EXTRA STRENGTH gas relief	SIMETHICONE	KRAMER LABORATORIES	d45ec9d0-f8b9-41ef-8dd9-11caf6a1b3eb	2025-12-19	Warnings	Exact identifier application number: M002
SIMETHICONE 80MG	SIMETHICONE	Cardinal Health 107, LLC	5e755184-0821-4f92-8f72-84726f7aa407	2025-12-18	Warnings	Exact identifier application number: M002
Gas Relief	SIMETHICONE CAPSULES USP, 125 MG	Dr. Reddy's Laboratories Inc.	b3069d83-5654-8469-302a-0f76c30e3976	2025-12-15	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
809376	MYLICON 20 MG in 0.3 mL Oral Suspension	PSN	395be942-d883-4bcb-8811-6fe1521d5a92	5
198857	simethicone 20 MG in 0.3 mL Oral Suspension	PSN	395be942-d883-4bcb-8811-6fe1521d5a92	5
809376	simethicone 66.7 MG/ML Oral Suspension [Mylicon]	SBD	395be942-d883-4bcb-8811-6fe1521d5a92	5
198857	simethicone 66.7 MG/ML Oral Suspension	SCD	395be942-d883-4bcb-8811-6fe1521d5a92	5
809376	Mylicon 20 MG per 0.3 ML Oral Suspension	SY	395be942-d883-4bcb-8811-6fe1521d5a92	5
809376	Mylicon 66.7 MG/ML Oral Suspension	SY	395be942-d883-4bcb-8811-6fe1521d5a92	5
198857	simethicone 20 MG per 0.3 ML Oral Suspension	SY	395be942-d883-4bcb-8811-6fe1521d5a92	5
198857	simethicone 40 MG per 0.6 ML Oral Suspension	SY	395be942-d883-4bcb-8811-6fe1521d5a92	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
62372-630-15	62372063015	1 BOTTLE, DROPPER in 1 CARTON (62372-630-15) / 15 mL in 1 BOTTLE, DROPPER	2015-03-31	0000-00-00	No	No	Current
62372-630-30	62372063030	1 BOTTLE, DROPPER in 1 CARTON (62372-630-30) / 30 mL in 1 BOTTLE, DROPPER	2015-03-31	0000-00-00	No	No	Current