Cough and Bronchial

Product NDC
53499-0293
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53499-0293DDiscontinued by firm2026-10-05
excluded packagepackage53499-029353499-0293-5DDiscontinued by firm2026-10-05
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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53499-0293-9d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53499-0293-5d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53499-0293-9f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53499-0293-5f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53499-0293-92ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53499-0293-52ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53499-0293-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53499-0293-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53499-0293-9cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53499-0293-5cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53499-0293-9cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53499-0293-5cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53499-0293-9302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53499-0293-5302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53499-0293-9ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53499-0293-5ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53499-0293-90efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53499-0293-50efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53499-0293-9ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53499-0293-5ad56d346431e…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
53499-0293-5534990293051 BOTTLE, PLASTIC in 1 CARTON (53499-0293-5) > 118 mL in 1 BOTTLE, PLASTIC2004-07-010000-00-00NoNoCurrent
53499-0293-9534990293091 BOTTLE, PLASTIC in 1 CARTON (53499-0293-9) > 237 mL in 1 BOTTLE, PLASTIC2004-07-010000-00-00NoNoCurrent