Cough and Bronchial

Product NDC
53499-0293
Requested package NDC
53499-0293-9
11-digit product format
534990293
Labeler code
53499
Product ID
53499-0293_7953d438-db43-4256-833e-6074e4bfcfb8
Type
HUMAN OTC DRUG
Nonproprietary name
ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN
Dosage form
SYRUP
Route
ORAL
Labeler
Schwabe North America
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2004-07-01
Marketing end
0000-00-00
Substance
ACONITUM NAPELLUS; BRYONIA ALBA ROOT; CALCIUM SULFIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; TIN
Active strength
3 [hp_X]/118mL; [hp_X]/118mL; [hp_C]/118mL; [hp_X]/118mL; [hp_C]/118mL
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage53499-029353499-0293-9DDiscontinued by firm2026-10-05

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 · 10 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…

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 INGREDIENTU0NQ8555JDCOUGH AND BRONCHIAL (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN) SYRUP [NATURE'S WAY PRODUCTS, LLC]3
BRYONIA ALBA ROOTACTIVE INGREDIENTT7J046YI2BCOUGH AND BRONCHIAL (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN) SYRUP [NATURE'S WAY PRODUCTS, LLC]3
CALCIUM SULFIDEACTIVE INGREDIENT1MBW07J51QCOUGH AND BRONCHIAL (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN) SYRUP [NATURE'S WAY PRODUCTS, LLC]3
SPONGIA OFFICINALIS SKELETON, ROASTEDACTIVE INGREDIENT1PIP394IIDCOUGH AND BRONCHIAL (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN) SYRUP [NATURE'S WAY PRODUCTS, LLC]3
TINACTIVE INGREDIENT387GMG9FH5COUGH AND BRONCHIAL (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN) SYRUP [NATURE'S WAY PRODUCTS, LLC]3
ACONITUM NAPELLUSACTIVE MOIETYU0NQ8555JDCOUGH AND BRONCHIAL (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN) SYRUP [NATURE'S WAY PRODUCTS, LLC]3
BRYONIA ALBA ROOTACTIVE MOIETYT7J046YI2BCOUGH AND BRONCHIAL (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN) SYRUP [NATURE'S WAY PRODUCTS, LLC]3
CALCIUM SULFIDEACTIVE MOIETY1MBW07J51QCOUGH AND BRONCHIAL (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN) SYRUP [NATURE'S WAY PRODUCTS, LLC]3
SPONGIA OFFICINALIS SKELETON, ROASTEDACTIVE MOIETY1PIP394IIDCOUGH AND BRONCHIAL (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN) SYRUP [NATURE'S WAY PRODUCTS, LLC]3
TINACTIVE MOIETY387GMG9FH5COUGH AND BRONCHIAL (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN) SYRUP [NATURE'S WAY PRODUCTS, LLC]3
ACACIAINACTIVE INGREDIENT5C5403N26OCOUGH AND BRONCHIAL (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN) SYRUP [NATURE'S WAY PRODUCTS, LLC]3
BARLEY MALTINACTIVE INGREDIENTR3NBG8914UCOUGH AND BRONCHIAL (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN) SYRUP [NATURE'S WAY PRODUCTS, LLC]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCOUGH AND BRONCHIAL (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN) SYRUP [NATURE'S WAY PRODUCTS, LLC]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCOUGH AND BRONCHIAL (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN) SYRUP [NATURE'S WAY PRODUCTS, LLC]3
SUCROSEINACTIVE INGREDIENTC151H8M554COUGH AND BRONCHIAL (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN) SYRUP [NATURE'S WAY PRODUCTS, LLC]3
WATERINACTIVE INGREDIENT059QF0KO0RCOUGH AND BRONCHIAL (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN) SYRUP [NATURE'S WAY PRODUCTS, LLC]3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53499-0293-9534990293091 BOTTLE, PLASTIC in 1 CARTON (53499-0293-9) > 237 mL in 1 BOTTLE, PLASTIC2004-07-010000-00-00NoNoCurrent