FDA.reportPublic FDA data

Tummy Ache 4Kids

Product NDC
54973-3196
11-digit product format
549733196
Labeler code
54973
Product ID
54973-3196_efce4dc3-032f-a57c-e053-2a95a90a9838
Type
HUMAN OTC DRUG
Nonproprietary name
silver nitrate, asafetida, activated charcoal, matricaria recutita, cinchona officinalis bark, citrullus colocynthis fruit pulp, lycopodium clavatum spore, nutmeg, and pulsatilla vulgaris
Dosage form
TABLET
Route
ORAL
Labeler
Hyland's Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2014-10-20
Marketing end
0000-00-00
Substance
ACTIVATED CHARCOAL; ASAFETIDA; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; NUTMEG; PULSATILLA VULGARIS; SILVER NITRATE
Active strength
12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACTIVATED CHARCOALACTIVE INGREDIENT2P3VWU3H10TUMMY ACHE 4KIDS (SILVER NITRATE, ASAFETIDA, ACTIVATED CHARCOAL, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, CITRULLUS COLOCYNTHIS FRUIT PULP, LYCOPODIUM CLAVATUM SPORE, NUTMEG, AND PULSATILLA VULGARIS) TABLET [HYLAND'S]1
ASAFETIDAACTIVE INGREDIENTW9FZA51AS1TUMMY ACHE 4KIDS (SILVER NITRATE, ASAFETIDA, ACTIVATED CHARCOAL, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, CITRULLUS COLOCYNTHIS FRUIT PULP, LYCOPODIUM CLAVATUM SPORE, NUTMEG, AND PULSATILLA VULGARIS) TABLET [HYLAND'S]1
CINCHONA OFFICINALIS BARKACTIVE INGREDIENTS003A158SBTUMMY ACHE 4KIDS (SILVER NITRATE, ASAFETIDA, ACTIVATED CHARCOAL, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, CITRULLUS COLOCYNTHIS FRUIT PULP, LYCOPODIUM CLAVATUM SPORE, NUTMEG, AND PULSATILLA VULGARIS) TABLET [HYLAND'S]1
CITRULLUS COLOCYNTHIS FRUIT PULPACTIVE INGREDIENT23H32AOH17TUMMY ACHE 4KIDS (SILVER NITRATE, ASAFETIDA, ACTIVATED CHARCOAL, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, CITRULLUS COLOCYNTHIS FRUIT PULP, LYCOPODIUM CLAVATUM SPORE, NUTMEG, AND PULSATILLA VULGARIS) TABLET [HYLAND'S]1
LYCOPODIUM CLAVATUM SPOREACTIVE INGREDIENTC88X29Y479TUMMY ACHE 4KIDS (SILVER NITRATE, ASAFETIDA, ACTIVATED CHARCOAL, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, CITRULLUS COLOCYNTHIS FRUIT PULP, LYCOPODIUM CLAVATUM SPORE, NUTMEG, AND PULSATILLA VULGARIS) TABLET [HYLAND'S]1
MATRICARIA RECUTITAACTIVE INGREDIENTG0R4UBI2ZZTUMMY ACHE 4KIDS (SILVER NITRATE, ASAFETIDA, ACTIVATED CHARCOAL, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, CITRULLUS COLOCYNTHIS FRUIT PULP, LYCOPODIUM CLAVATUM SPORE, NUTMEG, AND PULSATILLA VULGARIS) TABLET [HYLAND'S]1
NUTMEGACTIVE INGREDIENTAEE24M3MQ9TUMMY ACHE 4KIDS (SILVER NITRATE, ASAFETIDA, ACTIVATED CHARCOAL, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, CITRULLUS COLOCYNTHIS FRUIT PULP, LYCOPODIUM CLAVATUM SPORE, NUTMEG, AND PULSATILLA VULGARIS) TABLET [HYLAND'S]1
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEVTUMMY ACHE 4KIDS (SILVER NITRATE, ASAFETIDA, ACTIVATED CHARCOAL, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, CITRULLUS COLOCYNTHIS FRUIT PULP, LYCOPODIUM CLAVATUM SPORE, NUTMEG, AND PULSATILLA VULGARIS) TABLET [HYLAND'S]1
SILVER NITRATEACTIVE INGREDIENT95IT3W8JZETUMMY ACHE 4KIDS (SILVER NITRATE, ASAFETIDA, ACTIVATED CHARCOAL, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, CITRULLUS COLOCYNTHIS FRUIT PULP, LYCOPODIUM CLAVATUM SPORE, NUTMEG, AND PULSATILLA VULGARIS) TABLET [HYLAND'S]1
ACTIVATED CHARCOALACTIVE MOIETY2P3VWU3H10TUMMY ACHE 4KIDS (SILVER NITRATE, ASAFETIDA, ACTIVATED CHARCOAL, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, CITRULLUS COLOCYNTHIS FRUIT PULP, LYCOPODIUM CLAVATUM SPORE, NUTMEG, AND PULSATILLA VULGARIS) TABLET [HYLAND'S]1
ASAFETIDAACTIVE MOIETYW9FZA51AS1TUMMY ACHE 4KIDS (SILVER NITRATE, ASAFETIDA, ACTIVATED CHARCOAL, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, CITRULLUS COLOCYNTHIS FRUIT PULP, LYCOPODIUM CLAVATUM SPORE, NUTMEG, AND PULSATILLA VULGARIS) TABLET [HYLAND'S]1
CINCHONA OFFICINALIS BARKACTIVE MOIETYS003A158SBTUMMY ACHE 4KIDS (SILVER NITRATE, ASAFETIDA, ACTIVATED CHARCOAL, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, CITRULLUS COLOCYNTHIS FRUIT PULP, LYCOPODIUM CLAVATUM SPORE, NUTMEG, AND PULSATILLA VULGARIS) TABLET [HYLAND'S]1
CITRULLUS COLOCYNTHIS FRUIT PULPACTIVE MOIETY23H32AOH17TUMMY ACHE 4KIDS (SILVER NITRATE, ASAFETIDA, ACTIVATED CHARCOAL, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, CITRULLUS COLOCYNTHIS FRUIT PULP, LYCOPODIUM CLAVATUM SPORE, NUTMEG, AND PULSATILLA VULGARIS) TABLET [HYLAND'S]1
LYCOPODIUM CLAVATUM SPOREACTIVE MOIETYC88X29Y479TUMMY ACHE 4KIDS (SILVER NITRATE, ASAFETIDA, ACTIVATED CHARCOAL, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, CITRULLUS COLOCYNTHIS FRUIT PULP, LYCOPODIUM CLAVATUM SPORE, NUTMEG, AND PULSATILLA VULGARIS) TABLET [HYLAND'S]1
MATRICARIA RECUTITAACTIVE MOIETYG0R4UBI2ZZTUMMY ACHE 4KIDS (SILVER NITRATE, ASAFETIDA, ACTIVATED CHARCOAL, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, CITRULLUS COLOCYNTHIS FRUIT PULP, LYCOPODIUM CLAVATUM SPORE, NUTMEG, AND PULSATILLA VULGARIS) TABLET [HYLAND'S]1
NUTMEGACTIVE MOIETYAEE24M3MQ9TUMMY ACHE 4KIDS (SILVER NITRATE, ASAFETIDA, ACTIVATED CHARCOAL, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, CITRULLUS COLOCYNTHIS FRUIT PULP, LYCOPODIUM CLAVATUM SPORE, NUTMEG, AND PULSATILLA VULGARIS) TABLET [HYLAND'S]1
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEVTUMMY ACHE 4KIDS (SILVER NITRATE, ASAFETIDA, ACTIVATED CHARCOAL, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, CITRULLUS COLOCYNTHIS FRUIT PULP, LYCOPODIUM CLAVATUM SPORE, NUTMEG, AND PULSATILLA VULGARIS) TABLET [HYLAND'S]1
SILVER CATIONACTIVE MOIETY57N7B0K90ATUMMY ACHE 4KIDS (SILVER NITRATE, ASAFETIDA, ACTIVATED CHARCOAL, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, CITRULLUS COLOCYNTHIS FRUIT PULP, LYCOPODIUM CLAVATUM SPORE, NUTMEG, AND PULSATILLA VULGARIS) TABLET [HYLAND'S]1
ACACIAINACTIVE INGREDIENT5C5403N26OTUMMY ACHE 4KIDS (SILVER NITRATE, ASAFETIDA, ACTIVATED CHARCOAL, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, CITRULLUS COLOCYNTHIS FRUIT PULP, LYCOPODIUM CLAVATUM SPORE, NUTMEG, AND PULSATILLA VULGARIS) TABLET [HYLAND'S]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GTUMMY ACHE 4KIDS (SILVER NITRATE, ASAFETIDA, ACTIVATED CHARCOAL, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, CITRULLUS COLOCYNTHIS FRUIT PULP, LYCOPODIUM CLAVATUM SPORE, NUTMEG, AND PULSATILLA VULGARIS) TABLET [HYLAND'S]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-3196TUMMY ACHE 4KIDS (SILVER NITRATE, ASAFETIDA, ACTIVATED CHARCOAL, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, CITRULLUS COLOCYNTHIS FRUIT PULP, LYCOPODIUM CLAVATUM SPORE, NUTMEG, AND PULSATILLA VULGARIS) TABLET [HYLAND'S INC.]5Legacy NDC20221217_987988e0-e67e-4d46-b117-5ffa126885ff.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54973-3196-1549733196011 BOTTLE, PLASTIC in 1 CARTON (54973-3196-1) > 50 TABLET in 1 BOTTLE, PLASTIC2014-10-200000-00-00NoNoCurrent
54973-3196-3549733196034 TABLET in 1 PACKET (54973-3196-3) 4 tablet2014-10-200000-00-00NoNoCurrent