FDA.reportPublic FDA data

Nightime Cough and Bronchial

Product NDC
53499-0693
Requested package NDC
53499-0693-5
11-digit product format
534990693
Labeler code
53499
Product ID
53499-0693_08c5cc31-2ad6-4d93-84f4-948c3937c64f
Type
HUMAN OTC DRUG
Nonproprietary name
ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEAN
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; ARABICA COFFEE BEAN; BRYONIA ALBA ROOT; CALCIUM SULFIDE; MEDICAGO SATIVA LEAF; OAT; SPONGIA OFFICINALIS SKELETON, ROASTED; TIN
Active strength
3 [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_C]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_C]/118mL
Pharmacologic classes
Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], 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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53499-069353499-0693-5DDiscontinued by firm2026-08-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACONITUM NAPELLUSACTIVE INGREDIENTU0NQ8555JDNIGHTIME COUGH AND BRONCHIAL (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEAN) SYRUP [NATURE'S WAY PRODUCTS, INC.]3
ARABICA COFFEE BEANACTIVE INGREDIENT3SW678MX72NIGHTIME COUGH AND BRONCHIAL (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEAN) SYRUP [NATURE'S WAY PRODUCTS, INC.]3
BRYONIA ALBA ROOTACTIVE INGREDIENTT7J046YI2BNIGHTIME COUGH AND BRONCHIAL (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEAN) SYRUP [NATURE'S WAY PRODUCTS, INC.]3
CALCIUM SULFIDEACTIVE INGREDIENT1MBW07J51QNIGHTIME COUGH AND BRONCHIAL (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEAN) SYRUP [NATURE'S WAY PRODUCTS, INC.]3
MEDICAGO SATIVA LEAFACTIVE INGREDIENTHY3L927V6MNIGHTIME COUGH AND BRONCHIAL (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEAN) SYRUP [NATURE'S WAY PRODUCTS, INC.]3
OATACTIVE INGREDIENTZ6J799EAJKNIGHTIME COUGH AND BRONCHIAL (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEAN) SYRUP [NATURE'S WAY PRODUCTS, INC.]3
SPONGIA OFFICINALIS SKELETON, ROASTEDACTIVE INGREDIENT1PIP394IIDNIGHTIME COUGH AND BRONCHIAL (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEAN) SYRUP [NATURE'S WAY PRODUCTS, INC.]3
TINACTIVE INGREDIENT387GMG9FH5NIGHTIME COUGH AND BRONCHIAL (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEAN) SYRUP [NATURE'S WAY PRODUCTS, INC.]3
ACONITUM NAPELLUSACTIVE MOIETYU0NQ8555JDNIGHTIME COUGH AND BRONCHIAL (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEAN) SYRUP [NATURE'S WAY PRODUCTS, INC.]3
ARABICA COFFEE BEANACTIVE MOIETY3SW678MX72NIGHTIME COUGH AND BRONCHIAL (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEAN) SYRUP [NATURE'S WAY PRODUCTS, INC.]3
BRYONIA ALBA ROOTACTIVE MOIETYT7J046YI2BNIGHTIME COUGH AND BRONCHIAL (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEAN) SYRUP [NATURE'S WAY PRODUCTS, INC.]3
CALCIUM SULFIDEACTIVE MOIETY1MBW07J51QNIGHTIME COUGH AND BRONCHIAL (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEAN) SYRUP [NATURE'S WAY PRODUCTS, INC.]3
MEDICAGO SATIVA LEAFACTIVE MOIETYHY3L927V6MNIGHTIME COUGH AND BRONCHIAL (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEAN) SYRUP [NATURE'S WAY PRODUCTS, INC.]3
OATACTIVE MOIETYZ6J799EAJKNIGHTIME COUGH AND BRONCHIAL (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEAN) SYRUP [NATURE'S WAY PRODUCTS, INC.]3
SPONGIA OFFICINALIS SKELETON, ROASTEDACTIVE MOIETY1PIP394IIDNIGHTIME COUGH AND BRONCHIAL (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEAN) SYRUP [NATURE'S WAY PRODUCTS, INC.]3
TINACTIVE MOIETY387GMG9FH5NIGHTIME COUGH AND BRONCHIAL (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEAN) SYRUP [NATURE'S WAY PRODUCTS, INC.]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLNIGHTIME COUGH AND BRONCHIAL (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEAN) SYRUP [NATURE'S WAY PRODUCTS, INC.]3
BARLEY MALTINACTIVE INGREDIENTR3NBG8914UNIGHTIME COUGH AND BRONCHIAL (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEAN) SYRUP [NATURE'S WAY PRODUCTS, INC.]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUNIGHTIME COUGH AND BRONCHIAL (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEAN) SYRUP [NATURE'S WAY PRODUCTS, INC.]3
SUCROSEINACTIVE INGREDIENTC151H8M554NIGHTIME COUGH AND BRONCHIAL (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEAN) SYRUP [NATURE'S WAY PRODUCTS, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RNIGHTIME COUGH AND BRONCHIAL (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEAN) SYRUP [NATURE'S WAY PRODUCTS, INC.]3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53499-0693-5534990693051 BOTTLE, PLASTIC in 1 CARTON (53499-0693-5) > 118 mL in 1 BOTTLE, PLASTIC2004-07-010000-00-00NoNoCurrent