FDA.reportPublic FDA data

NDC 43857-0548-01 - Cough Syrup Formula

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
43857-0548
Requested NDC
43857-0548-01
Package NDCs from labels
43857-0548-1, 43857-0548-01
Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2024-01-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cough Syrup Formula - BioActive Nutritional, Inc. | Apotheca CompanyBioActive Nutritional, Inc. | Apotheca Company2024-01-05HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0548-12024-01-05C16284748780-1f386c649-ea93-0266-e053-dadaa90a7c1aDRUG FACTS:
43857-0548-12023-01-30C16284748780-1f386c649-ea93-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0548-1Cough Syrup Formula120 mL in 1 BOTTLELIQUID1203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0548COUGH SYRUP FORMULA (DROSERA (ROTUNDIFOLIA), COCCUS CACTI, SPONGIA TOSTA, BELLADONNA, CUPRUM ACETICUM, KALI CARBONICUM, MENTHA PIPERITA, PHOSPHORUS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]3Current NDC, Legacy NDC, 1 package rows20240106_ade129ac-3a50-47fe-87be-8efc3a64d2cd.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 6 of 225 · 4,487 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smooth Breath Spasmodic coughBRYONIA 5C, DROSERA 5C, MENTHA PIPERITA 3C, SPONGIA TOSTA 5C, VERBASCUM THAPSUS 3C, VIOLA ODORATA 3CSEVENE USA54eb17ad-c834-db86-e063-6294a90a58972026-08-18WarningsExact identifier
unii: 79M2M2UDA9
unii: QR44N9XPJQ
AlcoholALCOHOLLidl US, LLCc7746330-2943-491a-bafc-0c8dd4fa40e22026-08-18Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLNice-Pak Products, LLCdc071394-60de-4b13-a962-9a643b01b1062026-08-18Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
HDXETHYL ALCOHOLApollo Health and Beauty Caredf0063b2-2e30-428e-b5cf-24e566c388c22026-08-18WarningsExact identifier
unii: 3K9958V90M
WISH ADVANCED HAND SANITIZER BLACK PLUM VANILLAALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA595f0c9f-645d-a047-e063-6294a90a996a2026-08-18WarningsExact identifier
unii: 3K9958V90M
WISH HAND SANITIZER cherry rougeALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA593a7fc9-8d56-f9cb-e063-6294a90a3dae2026-08-17WarningsExact identifier
unii: 3K9958V90M
Ethyl alcohol 62%ETHYL ALCOHOL 62%UpLift Brands LLC5941ee9e-d109-b2be-e063-6394a90aa3232026-08-17Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
CVS Anti Nausea Cherry FlavorDEXTROSE(GLUCOSE),LEVULOSE(FRUCTOSE),PHOSPHORIC ACIDCVS PHARMACYf6f7568b-3887-434d-9403-a3ecdc591bbc2026-08-17WarningsExact identifier
unii: IY9XDZ35W2
WISH HAND SANITIZER Sea Salt Green HerbsALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA59259ea7-f1bb-9688-e063-6394a90afb3c2026-08-16WarningsExact identifier
unii: 3K9958V90M
WISH HAND SANITIZER Marshmallow VanillaALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA5925e9a7-eb93-c0e3-e063-6294a90ad2652026-08-16WarningsExact identifier
unii: 3K9958V90M
WISH HAND SANITIZER Lychee Vanilla MilkALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA592625c8-cbc5-f864-e063-6394a90aeb9d2026-08-16WarningsExact identifier
unii: 3K9958V90M
WISH HAND SANITIZER Banana Cream SugarALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA5912d7e8-94a7-e8b9-e063-6394a90a74d62026-08-15WarningsExact identifier
unii: 3K9958V90M
WISH HAND SANITIZER Caramel Vanilla PopcornALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA591317be-856e-1374-e063-6394a90a7aaf2026-08-15WarningsExact identifier
unii: 3K9958V90M
WISH HAND SANITIZER Strawberry MuskALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA59143edb-41fe-0a1f-e063-6394a90a81a52026-08-15WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST ICED SUGAR COOKIE SCENTETHYL ALCOHOLAmber Glow Cosmetics Limitedb83a5eef-e2ae-4044-9dce-fd69a5ec5e812026-08-14WarningsExact identifier
unii: 3K9958V90M
WISH HAND SANITIZER Rose WoodsALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA58fb4491-2918-c486-e063-6394a90a621f2026-08-14WarningsExact identifier
unii: 3K9958V90M
Alcohol Sanitizer Spray.ETHYL ALCOHOLGuangdong Yanze Biotechnology Co., Ltd.58fb9efe-43f0-1b7f-e063-6394a90a01452026-08-14WarningsExact identifier
unii: 3K9958V90M
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
BM BM220 DROPSBAPTISIA, CHAMOMILLA, CHINA OFF, COLOCYNTHIS, DULCAMARA, MERC DUL, PODOPHYLLUMBM Private Limited590adab5-9c66-e7e2-e063-6394a90a6b4c2026-08-14WarningsExact identifier
unii: FGL3685T2X
FRESH FEELS HAND SANITIZER MIST CHILL COCONUT SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited6da508ab-176c-4cca-aa1b-c161d9160cd12026-08-14WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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