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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE20 mg/.3mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O
Rxcui198857

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-1303-1Infants120 in 1 BOX, UNIT-DOSESUSPENSION/ DROPS1202
17856-1303-1Infants0.3 mL in 1 SYRINGESUSPENSION/ DROPS0.32
17856-1303-2Infants0.3 mL in 1 SYRINGESUSPENSION/ DROPS0.32
17856-1303-2Infants120 in 1 BOX, UNIT-DOSESUSPENSION/ DROPS1202
17856-1303-3Infants0.6 mL in 1 SYRINGESUSPENSION/ DROPS0.62
17856-1303-3Infants120 in 1 BOX, UNIT-DOSESUSPENSION/ DROPS1202
17856-1303-4Infants120 in 1 BOX, UNIT-DOSESUSPENSION/ DROPS1202
17856-1303-4Infants0.6 mL in 1 SYRINGESUSPENSION/ DROPS0.62
17856-1303-5Infants1.2 mL in 1 SYRINGESUSPENSION/ DROPS1.22
17856-1303-5Infants60 in 1 BOX, UNIT-DOSESUSPENSION/ DROPS602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-1303-1EA - Each17856-1303b8601f9f-9eb1-4837-a529-b4cf80be384a12025-12-16
17856-1303-2EA - Each17856-1303786ecd51-d680-46a0-bbb9-cd4ef81721b912022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-1303INFANTS (SIMETHICONE) SUSPENSION/ DROPS [ATLANTIC BIOLOGICALS CORP.]2Current NDC, Legacy NDC, 10 package rows20250426_27fce442-e328-41d2-bab9-87ab21550c04.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198857simethicone 20 MG in 0.3 mL Oral SuspensionPSN27fce442-e328-41d2-bab9-87ab21550c042
198857simethicone 66.7 MG/ML Oral SuspensionSCD27fce442-e328-41d2-bab9-87ab21550c042
198857simethicone 20 MG per 0.3 ML Oral SuspensionSY27fce442-e328-41d2-bab9-87ab21550c042
198857simethicone 40 MG per 0.6 ML Oral SuspensionSY27fce442-e328-41d2-bab9-87ab21550c042

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-1303-117856130301120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1303-1) / .3 mL in 1 SYRINGE120 syringe2021-06-300000-00-00NoNoCurrent
17856-1303-217856130302120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1303-2) / .3 mL in 1 SYRINGE120 syringe2021-06-300000-00-00NoNoCurrent
17856-1303-317856130303120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1303-3) / .6 mL in 1 SYRINGE120 syringe2021-06-300000-00-00NoNoCurrent
17856-1303-417856130304120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1303-4) / .6 mL in 1 SYRINGE120 syringe2021-06-300000-00-00NoNoCurrent
17856-1303-51785613030560 SYRINGE in 1 BOX, UNIT-DOSE (17856-1303-5) / 1.2 mL in 1 SYRINGE60 syringe2021-06-300000-00-00NoNoCurrent