Betula Spiraea

Product NDC
48951-2068
11-digit product format
489512068
Labeler code
48951
Product ID
48951-2068_6c7e63c2-42a1-2be2-e053-2a91aa0a6af3
Type
HUMAN OTC DRUG
Nonproprietary name
Betula spiraea
Dosage form
LIQUID
Route
ORAL
Labeler
Uriel Pharmacy Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2009-09-01
Marketing end
0000-00-00
Substance
BETULA PUBESCENS BARK; BETULA PUBESCENS LEAF; FILIPENDULA ULMARIA ROOT; MANDRAGORA OFFICINARUM ROOT; LEAD; FORMICA RUFA; ARNICA MONTANA; EQUISETUM ARVENSE TOP
Active strength
3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct48951-2068IInactivated by FDA2026-10-05
excluded packagepackage48951-206848951-2068-1IInactivated by FDA2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-2068-1Betula Spiraea10 in 1 PACKAGELIQUID105
48951-2068-1Betula Spiraea1 mL in 1 PACKAGELIQUID15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZWBETULA SPIRAEA LIQUID [URIEL PHARMACY INC.]1
BETULA PUBESCENS BARKACTIVE INGREDIENT3R504894L9BETULA SPIRAEA LIQUID [URIEL PHARMACY INC.]1
BETULA PUBESCENS LEAFACTIVE INGREDIENT84SOH0O3OOBETULA SPIRAEA LIQUID [URIEL PHARMACY INC.]1
EQUISETUM ARVENSE TOPACTIVE INGREDIENT1DP6Y6B65ZBETULA SPIRAEA LIQUID [URIEL PHARMACY INC.]1
FILIPENDULA ULMARIA ROOTACTIVE INGREDIENT997724QNDSBETULA SPIRAEA LIQUID [URIEL PHARMACY INC.]1
FORMICA RUFAACTIVE INGREDIENT55H0W83JO5BETULA SPIRAEA LIQUID [URIEL PHARMACY INC.]1
LEADACTIVE INGREDIENT2P299V784PBETULA SPIRAEA LIQUID [URIEL PHARMACY INC.]1
MANDRAGORA OFFICINARUM ROOTACTIVE INGREDIENTI2XCB174VBBETULA SPIRAEA LIQUID [URIEL PHARMACY INC.]1
ARNICA MONTANAACTIVE MOIETYO80TY208ZWBETULA SPIRAEA LIQUID [URIEL PHARMACY INC.]1
BETULA PUBESCENS BARKACTIVE MOIETY3R504894L9BETULA SPIRAEA LIQUID [URIEL PHARMACY INC.]1
BETULA PUBESCENS LEAFACTIVE MOIETY84SOH0O3OOBETULA SPIRAEA LIQUID [URIEL PHARMACY INC.]1
EQUISETUM ARVENSE TOPACTIVE MOIETY1DP6Y6B65ZBETULA SPIRAEA LIQUID [URIEL PHARMACY INC.]1
FILIPENDULA ULMARIA ROOTACTIVE MOIETY997724QNDSBETULA SPIRAEA LIQUID [URIEL PHARMACY INC.]1
FORMICA RUFAACTIVE MOIETY55H0W83JO5BETULA SPIRAEA LIQUID [URIEL PHARMACY INC.]1
LEADACTIVE MOIETY2P299V784PBETULA SPIRAEA LIQUID [URIEL PHARMACY INC.]1
MANDRAGORA OFFICINARUM ROOTACTIVE MOIETYI2XCB174VBBETULA SPIRAEA LIQUID [URIEL PHARMACY INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XBETULA SPIRAEA LIQUID [URIEL PHARMACY INC.]1
waterINACTIVE INGREDIENT059QF0KO0RBETULA SPIRAEA LIQUID [URIEL PHARMACY INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-2068BETULA SPIRAEA LIQUID [URIEL PHARMACY INC.]5Legacy NDC, 2 package rows20240402_32604217-7955-492e-9df6-9e4882566ac4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
48951-2068-14895120680110 PACKAGE in 1 PACKAGE (48951-2068-1) > 1 mL in 1 PACKAGE10 package2009-09-010000-00-00NoNoCurrent