4 Kids Stuffy Nose and Sinus

Product NDC
54973-3406
11-digit product format
549733406
Labeler code
54973
Product ID
54973-3406_387c5392-b956-044f-e063-6394a90a9d86
Type
HUMAN OTC DRUG
Nonproprietary name
PULSATILLA PRATENSIS WHOLE,OYSTER SHELL CALCIUM CARBONATE, CRUDE,GOLDENSEAL and POTASSIUM DICHROMATE
Dosage form
TABLET
Route
ORAL
Labeler
Hyland�s Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2020-01-27
Substance
GOLDENSEAL; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM DICHROMATE; PULSATILLA PRATENSIS WHOLE
Active strength
6; 3; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 packagepackage54973-340654973-3406-2DDiscontinued by firm2026-08-07

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…

Additional Listing Data#

Finished product
Yes
Brand name base
4 Kids Stuffy Nose and Sinus
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OYSTER SHELL CALCIUM CARBONATE, CRUDE6 [hp_X]/1
GOLDENSEAL3 [hp_X]/1
POTASSIUM DICHROMATE6 [hp_X]/1
PULSATILLA PRATENSIS WHOLE6 [hp_X]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2E32821G6IInternal UNII lookup
ZW3Z11D0JVInternal UNII lookup
T4423S18FMInternal UNII lookup
8E272251DIInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a00f1db3-cae4-5729-e053-2a95a90ab001Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-3406-14 Kids Stuffy Nose and Sinus1 in 1 CARTONTABLET16
54973-3406-14 Kids Stuffy Nose and Sinus50 in 1 BOTTLE, PLASTICTABLET506
54973-3406-24 Kids Stuffy Nose and Sinus16 in 1 BOTTLE, PLASTICTABLET166
54973-3406-24 Kids Stuffy Nose and Sinus1 in 1 CARTONTABLET16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-34064 KIDS STUFFY NOSE AND SINUS (PULSATILLA PRATENSIS WHOLE,OYSTER SHELL CALCIUM CARBONATE, CRUDE,GOLDENSEAL AND POTASSIUM DICHROMATE) TABLET [HYLAND’S INC.]5Current NDC, Legacy NDC, 4 package rows20230307_a00f1db3-cae4-5729-e053-2a95a90ab001.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
4 Kids Stuffy Nose and SinusPULSATILLA PRATENSIS WHOLE,OYSTER SHELL CALCIUM CARBONATE, CRUDE,GOLDENSEAL AND POTASSIUM DICHROMATEHylands Inc.a00f1db3-cae4-5729-e053-2a95a90ab0012025-06-26WarningsExact identifier
ndc (product): 54973-3406

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
54973-3406-1549733406011 BOTTLE, PLASTIC in 1 CARTON (54973-3406-1) / 50 TABLET in 1 BOTTLE, PLASTIC2020-01-270000-00-00NoNoCurrent
54973-3406-2549733406021 BOTTLE, PLASTIC in 1 CARTON (54973-3406-2) > 16 TABLET in 1 BOTTLE, PLASTIC2020-01-270000-00-00NoNoCurrent