INFANTS GAS AND COLIC RELIEF

Product NDC
63388-643
11-digit product format
633880643
Labeler code
63388
Product ID
63388-643_40aab71f-dd59-795e-e063-6394a90a75ab
Type
HUMAN OTC DRUG
Nonproprietary name
COLOCYNTHIS, MAGNESIA PHOSPHORICA, CHAMOMILLA, DIOSCOREA VILLOSA
Dosage form
LIQUID
Route
ORAL
Labeler
Laboratoire Atlas Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2014-02-19
Substance
CHAMOMILE; CITRULLUS COLOCYNTHIS FRUIT PULP; DIOSCOREA VILLOSA ROOT; MAGNESIUM PHOSPHATE, DIBASIC
Active strength
6; 6; 6; 6 [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL
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 1 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63388-643-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63388-643-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63388-643-02557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage63388-643-028af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63388-643-02834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63388-643-021332a3947898…d4bfe170f9cd…

Additional Listing Data#

Finished product
Yes
Brand name base
INFANTS GAS AND COLIC RELIEF
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CITRULLUS COLOCYNTHIS FRUIT PULP6 [hp_X]/25mL
MAGNESIUM PHOSPHATE, DIBASIC6 [hp_X]/25mL
CHAMOMILE6 [hp_X]/25mL
DIOSCOREA VILLOSA ROOT6 [hp_X]/25mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
23H32AOH17Internal UNII lookup
A1Y870209ZInternal UNII lookup
FGL3685T2XInternal UNII lookup
IWY3IWX2G8Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
feb6c271-182d-4a4c-bb2d-d1a87c76c7efAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-11-28Drug Facts
2024-11-28Drug Facts
2024-01-30Drug Facts
2024-01-30Drug Facts
2020-02-07Drug Facts
2020-02-07Drug Facts
2020-01-31Drug Facts
2020-01-31Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63388-643-02INFANTS GAS AND COLIC RELIEF1 in 1 CARTONLIQUID16
63388-643-02INFANTS GAS AND COLIC RELIEF25 mL in 1 BOTTLELIQUID256

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63388-643INFANTS GAS AND COLIC RELIEF (COLOCYNTHIS, MAGNESIA PHOSPHORICA, CHAMOMILLA, DIOSCOREA VILLOSA) LIQUID [LABORATOIRE ATLAS INC]5Current NDC, Legacy NDC, 2 package rows20241128_feb6c271-182d-4a4c-bb2d-d1a87c76c7ef.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INFANTS GAS AND COLIC RELIEFCOLOCYNTHIS, MAGNESIA PHOSPHORICA, CHAMOMILLA, DIOSCOREA VILLOSALaboratoire Atlas Incfeb6c271-182d-4a4c-bb2d-d1a87c76c7ef2025-10-08WarningsExact identifier
ndc (product): 63388-643

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63388-643-02633880643021 BOTTLE in 1 CARTON (63388-643-02) / 25 mL in 1 BOTTLE1 bottle2014-02-190000-00-00NoNoCurrent