FDA.reportPublic FDA data

Complete Allergy 4 Kids

Product NDC
54973-3097
Requested package NDC
54973-3097-1
11-digit product format
549733097
Labeler code
54973
Product ID
54973-3097_c6a1bbf1-692a-ceec-e053-2a95a90a84b6
Type
HUMAN OTC DRUG
Nonproprietary name
aconitum napellus, onion, euphrasia stricta, galphimia glauca flowering top, histamine dihydrochloride, luffa operculata fruit, sodium chloride, strychnos nux-vomica seed, pulsatilla vulgaris, and schoenocaulon officinale seed
Dosage form
LIQUID
Route
ORAL
Labeler
Hyland's, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2010-07-01
Marketing end
0000-00-00
Substance
ACONITUM NAPELLUS; ONION; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; LUFFA OPERCULATA FRUIT; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED
Active strength
6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage54973-309754973-3097-1DDiscontinued by firm2026-10-20

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, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACONITUM NAPELLUSACTIVE INGREDIENTU0NQ8555JDCOMPLETE ALLERGY 4 KIDS (ACONITUM NAPELLUS, ONION, EUPHRASIA STRICTA, GALPHIMIA GLAUCA FLOWERING TOP, HISTAMINE DIHYDROCHLORIDE, LUFFA OPERCULATA FRUIT, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PULSATILLA VULGARIS, AND SCHOENOCAULON OFFICINALE SEED) LIQUID [HYLAND'S, INC.]3
EUPHRASIA STRICTAACTIVE INGREDIENTC9642I91WLCOMPLETE ALLERGY 4 KIDS (ACONITUM NAPELLUS, ONION, EUPHRASIA STRICTA, GALPHIMIA GLAUCA FLOWERING TOP, HISTAMINE DIHYDROCHLORIDE, LUFFA OPERCULATA FRUIT, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PULSATILLA VULGARIS, AND SCHOENOCAULON OFFICINALE SEED) LIQUID [HYLAND'S, INC.]3
GALPHIMIA GLAUCA FLOWERING TOPACTIVE INGREDIENT93PH5Q8M7ECOMPLETE ALLERGY 4 KIDS (ACONITUM NAPELLUS, ONION, EUPHRASIA STRICTA, GALPHIMIA GLAUCA FLOWERING TOP, HISTAMINE DIHYDROCHLORIDE, LUFFA OPERCULATA FRUIT, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PULSATILLA VULGARIS, AND SCHOENOCAULON OFFICINALE SEED) LIQUID [HYLAND'S, INC.]3
HISTAMINE DIHYDROCHLORIDEACTIVE INGREDIENT3POA0Q644UCOMPLETE ALLERGY 4 KIDS (ACONITUM NAPELLUS, ONION, EUPHRASIA STRICTA, GALPHIMIA GLAUCA FLOWERING TOP, HISTAMINE DIHYDROCHLORIDE, LUFFA OPERCULATA FRUIT, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PULSATILLA VULGARIS, AND SCHOENOCAULON OFFICINALE SEED) LIQUID [HYLAND'S, INC.]3
LUFFA OPERCULATA FRUITACTIVE INGREDIENTC4MO6809HUCOMPLETE ALLERGY 4 KIDS (ACONITUM NAPELLUS, ONION, EUPHRASIA STRICTA, GALPHIMIA GLAUCA FLOWERING TOP, HISTAMINE DIHYDROCHLORIDE, LUFFA OPERCULATA FRUIT, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PULSATILLA VULGARIS, AND SCHOENOCAULON OFFICINALE SEED) LIQUID [HYLAND'S, INC.]3
ONIONACTIVE INGREDIENT492225Q21HCOMPLETE ALLERGY 4 KIDS (ACONITUM NAPELLUS, ONION, EUPHRASIA STRICTA, GALPHIMIA GLAUCA FLOWERING TOP, HISTAMINE DIHYDROCHLORIDE, LUFFA OPERCULATA FRUIT, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PULSATILLA VULGARIS, AND SCHOENOCAULON OFFICINALE SEED) LIQUID [HYLAND'S, INC.]3
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEVCOMPLETE ALLERGY 4 KIDS (ACONITUM NAPELLUS, ONION, EUPHRASIA STRICTA, GALPHIMIA GLAUCA FLOWERING TOP, HISTAMINE DIHYDROCHLORIDE, LUFFA OPERCULATA FRUIT, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PULSATILLA VULGARIS, AND SCHOENOCAULON OFFICINALE SEED) LIQUID [HYLAND'S, INC.]3
SCHOENOCAULON OFFICINALE SEEDACTIVE INGREDIENT6NAF1689IOCOMPLETE ALLERGY 4 KIDS (ACONITUM NAPELLUS, ONION, EUPHRASIA STRICTA, GALPHIMIA GLAUCA FLOWERING TOP, HISTAMINE DIHYDROCHLORIDE, LUFFA OPERCULATA FRUIT, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PULSATILLA VULGARIS, AND SCHOENOCAULON OFFICINALE SEED) LIQUID [HYLAND'S, INC.]3
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XCOMPLETE ALLERGY 4 KIDS (ACONITUM NAPELLUS, ONION, EUPHRASIA STRICTA, GALPHIMIA GLAUCA FLOWERING TOP, HISTAMINE DIHYDROCHLORIDE, LUFFA OPERCULATA FRUIT, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PULSATILLA VULGARIS, AND SCHOENOCAULON OFFICINALE SEED) LIQUID [HYLAND'S, INC.]3
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH13919COMPLETE ALLERGY 4 KIDS (ACONITUM NAPELLUS, ONION, EUPHRASIA STRICTA, GALPHIMIA GLAUCA FLOWERING TOP, HISTAMINE DIHYDROCHLORIDE, LUFFA OPERCULATA FRUIT, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PULSATILLA VULGARIS, AND SCHOENOCAULON OFFICINALE SEED) LIQUID [HYLAND'S, INC.]3
ACONITUM NAPELLUSACTIVE MOIETYU0NQ8555JDCOMPLETE ALLERGY 4 KIDS (ACONITUM NAPELLUS, ONION, EUPHRASIA STRICTA, GALPHIMIA GLAUCA FLOWERING TOP, HISTAMINE DIHYDROCHLORIDE, LUFFA OPERCULATA FRUIT, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PULSATILLA VULGARIS, AND SCHOENOCAULON OFFICINALE SEED) LIQUID [HYLAND'S, INC.]3
EUPHRASIA STRICTAACTIVE MOIETYC9642I91WLCOMPLETE ALLERGY 4 KIDS (ACONITUM NAPELLUS, ONION, EUPHRASIA STRICTA, GALPHIMIA GLAUCA FLOWERING TOP, HISTAMINE DIHYDROCHLORIDE, LUFFA OPERCULATA FRUIT, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PULSATILLA VULGARIS, AND SCHOENOCAULON OFFICINALE SEED) LIQUID [HYLAND'S, INC.]3
GALPHIMIA GLAUCA FLOWERING TOPACTIVE MOIETY93PH5Q8M7ECOMPLETE ALLERGY 4 KIDS (ACONITUM NAPELLUS, ONION, EUPHRASIA STRICTA, GALPHIMIA GLAUCA FLOWERING TOP, HISTAMINE DIHYDROCHLORIDE, LUFFA OPERCULATA FRUIT, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PULSATILLA VULGARIS, AND SCHOENOCAULON OFFICINALE SEED) LIQUID [HYLAND'S, INC.]3
HISTAMINEACTIVE MOIETY820484N8I3COMPLETE ALLERGY 4 KIDS (ACONITUM NAPELLUS, ONION, EUPHRASIA STRICTA, GALPHIMIA GLAUCA FLOWERING TOP, HISTAMINE DIHYDROCHLORIDE, LUFFA OPERCULATA FRUIT, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PULSATILLA VULGARIS, AND SCHOENOCAULON OFFICINALE SEED) LIQUID [HYLAND'S, INC.]3
LUFFA OPERCULATA FRUITACTIVE MOIETYC4MO6809HUCOMPLETE ALLERGY 4 KIDS (ACONITUM NAPELLUS, ONION, EUPHRASIA STRICTA, GALPHIMIA GLAUCA FLOWERING TOP, HISTAMINE DIHYDROCHLORIDE, LUFFA OPERCULATA FRUIT, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PULSATILLA VULGARIS, AND SCHOENOCAULON OFFICINALE SEED) LIQUID [HYLAND'S, INC.]3
ONIONACTIVE MOIETY492225Q21HCOMPLETE ALLERGY 4 KIDS (ACONITUM NAPELLUS, ONION, EUPHRASIA STRICTA, GALPHIMIA GLAUCA FLOWERING TOP, HISTAMINE DIHYDROCHLORIDE, LUFFA OPERCULATA FRUIT, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PULSATILLA VULGARIS, AND SCHOENOCAULON OFFICINALE SEED) LIQUID [HYLAND'S, INC.]3
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEVCOMPLETE ALLERGY 4 KIDS (ACONITUM NAPELLUS, ONION, EUPHRASIA STRICTA, GALPHIMIA GLAUCA FLOWERING TOP, HISTAMINE DIHYDROCHLORIDE, LUFFA OPERCULATA FRUIT, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PULSATILLA VULGARIS, AND SCHOENOCAULON OFFICINALE SEED) LIQUID [HYLAND'S, INC.]3
SCHOENOCAULON OFFICINALE SEEDACTIVE MOIETY6NAF1689IOCOMPLETE ALLERGY 4 KIDS (ACONITUM NAPELLUS, ONION, EUPHRASIA STRICTA, GALPHIMIA GLAUCA FLOWERING TOP, HISTAMINE DIHYDROCHLORIDE, LUFFA OPERCULATA FRUIT, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PULSATILLA VULGARIS, AND SCHOENOCAULON OFFICINALE SEED) LIQUID [HYLAND'S, INC.]3
SODIUM CATIONACTIVE MOIETYLYR4M0NH37COMPLETE ALLERGY 4 KIDS (ACONITUM NAPELLUS, ONION, EUPHRASIA STRICTA, GALPHIMIA GLAUCA FLOWERING TOP, HISTAMINE DIHYDROCHLORIDE, LUFFA OPERCULATA FRUIT, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PULSATILLA VULGARIS, AND SCHOENOCAULON OFFICINALE SEED) LIQUID [HYLAND'S, INC.]3
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH13919COMPLETE ALLERGY 4 KIDS (ACONITUM NAPELLUS, ONION, EUPHRASIA STRICTA, GALPHIMIA GLAUCA FLOWERING TOP, HISTAMINE DIHYDROCHLORIDE, LUFFA OPERCULATA FRUIT, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PULSATILLA VULGARIS, AND SCHOENOCAULON OFFICINALE SEED) LIQUID [HYLAND'S, INC.]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCOMPLETE ALLERGY 4 KIDS (ACONITUM NAPELLUS, ONION, EUPHRASIA STRICTA, GALPHIMIA GLAUCA FLOWERING TOP, HISTAMINE DIHYDROCHLORIDE, LUFFA OPERCULATA FRUIT, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PULSATILLA VULGARIS, AND SCHOENOCAULON OFFICINALE SEED) LIQUID [HYLAND'S, INC.]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOMPLETE ALLERGY 4 KIDS (ACONITUM NAPELLUS, ONION, EUPHRASIA STRICTA, GALPHIMIA GLAUCA FLOWERING TOP, HISTAMINE DIHYDROCHLORIDE, LUFFA OPERCULATA FRUIT, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PULSATILLA VULGARIS, AND SCHOENOCAULON OFFICINALE SEED) LIQUID [HYLAND'S, INC.]3
GLYCYRRHIZA GLABRAINACTIVE INGREDIENT2788Z9758HCOMPLETE ALLERGY 4 KIDS (ACONITUM NAPELLUS, ONION, EUPHRASIA STRICTA, GALPHIMIA GLAUCA FLOWERING TOP, HISTAMINE DIHYDROCHLORIDE, LUFFA OPERCULATA FRUIT, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PULSATILLA VULGARIS, AND SCHOENOCAULON OFFICINALE SEED) LIQUID [HYLAND'S, INC.]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCOMPLETE ALLERGY 4 KIDS (ACONITUM NAPELLUS, ONION, EUPHRASIA STRICTA, GALPHIMIA GLAUCA FLOWERING TOP, HISTAMINE DIHYDROCHLORIDE, LUFFA OPERCULATA FRUIT, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PULSATILLA VULGARIS, AND SCHOENOCAULON OFFICINALE SEED) LIQUID [HYLAND'S, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RCOMPLETE ALLERGY 4 KIDS (ACONITUM NAPELLUS, ONION, EUPHRASIA STRICTA, GALPHIMIA GLAUCA FLOWERING TOP, HISTAMINE DIHYDROCHLORIDE, LUFFA OPERCULATA FRUIT, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PULSATILLA VULGARIS, AND SCHOENOCAULON OFFICINALE SEED) LIQUID [HYLAND'S, INC.]3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54973-3097-154973309701118 mL in 1 BOTTLE, PLASTIC (54973-3097-1) 118 ml2010-07-010000-00-00NoNoCurrent