FDA.reportPublic FDA data

Opium Tincture Deodorized

Product NDC
42799-217
11-digit product format
427990217
Labeler code
42799
Product ID
42799-217_46e15fdb-940a-7018-e063-6294a90a9cc1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Morphine
Dosage form
TINCTURE
Route
ORAL
Labeler
Edenbridge Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2010-07-15
Substance
MORPHINE
Active strength
10 mg/mL
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Opium Tincture Deodorized
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MORPHINE10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
76I7G6D29CInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
830196Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e2a5697a-cc41-4cf1-b3a8-59b0268740d7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
89941d4c-522d-cee0-b273-43cfa7ef6d35Product name420250516
f15f9e76-db42-8a50-218a-5ef5affa58daProduct name420240216
944b0689-73f4-6a2f-c654-1180896353c0Product name420220210
67e166c6-23d4-4709-b77d-5ca6182dcae0Product name120180830
c573a64c-fe17-2eac-fbcb-788868b4ff6bProduct name920180619
7c1819cf-69a0-41dc-aeaa-a820729bc959Product name120170406
7a68fc31-10e5-df04-67e0-3a613a2d4d2eProduct name520161114
175682a8-c657-45a2-9dfb-c565306b03c8Product name120160112
b73dadd0-1b4a-4f88-956f-a2be216c8fadProduct name120151123
4c272b1c-87fc-ebc0-994d-ac28b1e0416eProduct name120140508
7a537f54-d322-5e54-a3a2-035d3e21c3c6Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42799-217-01Opium Tincture Deodorized118 mL in 1 BOTTLE, PLASTICTINCTURE1187
42799-217-02Opium Tincture Deodorized473 mL in 1 BOTTLE, PLASTICTINCTURE4737

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42799-217-01ML - Milliliter42799-2170bb4f2e5-869d-40ee-84d2-461e8096980d12012-07-24
42799-217-02ML - Milliliter42799-217d9b07394-1414-49d6-b97f-7b2e9db5cc2212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MorphineACTIVE INGREDIENT76I7G6D29COPIUM TINCTURE DEODORIZED (MORPHINE) TINCTURE [EDENBRIDGE PHARMACEUTICALS, LLC]2
MorphineACTIVE MOIETY76I7G6D29COPIUM TINCTURE DEODORIZED (MORPHINE) TINCTURE [EDENBRIDGE PHARMACEUTICALS, LLC]2
AlcoholINACTIVE INGREDIENT3K9958V90MOPIUM TINCTURE DEODORIZED (MORPHINE) TINCTURE [EDENBRIDGE PHARMACEUTICALS, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42799-217OPIUM TINCTURE DEODORIZED (MORPHINE) TINCTURE [EDENBRIDGE PHARMACEUTICALS, LLC]5Current NDC, Legacy NDC, 2 package rows20171011_e2a5697a-cc41-4cf1-b3a8-59b0268740d7.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Opium Tincture DeodorizedMORPHINEEdenbridge Pharmaceuticals, LLCe2a5697a-cc41-4cf1-b3a8-59b0268740d72025-12-26Warnings, Adverse reactionsExact identifier
ndc (product): 42799-217

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830196opium tincture 10 MG (as morphine equivalent) in 1 mL Oral SolutionPSNe2a5697a-cc41-4cf1-b3a8-59b0268740d77
830196opium tincture 100 MG/ML Oral SolutionSCDe2a5697a-cc41-4cf1-b3a8-59b0268740d77
830196anhydrous morphine 1 % Oral SolutionSYe2a5697a-cc41-4cf1-b3a8-59b0268740d77
830196anhydrous morphine 10 MG/ML Oral SolutionSYe2a5697a-cc41-4cf1-b3a8-59b0268740d77
830196opium tincture 10 % Oral SolutionSYe2a5697a-cc41-4cf1-b3a8-59b0268740d77
830196opium tincture 10 MG (as morphine equivalent) per 1 ML Oral SolutionSYe2a5697a-cc41-4cf1-b3a8-59b0268740d77

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42799-217-0142799021701118 mL in 1 BOTTLE, PLASTIC (42799-217-01) 118 ml2010-07-150000-00-00NoNoCurrent
42799-217-0242799021702473 mL in 1 BOTTLE, PLASTIC (42799-217-02) 473 ml2010-07-150000-00-00NoNoCurrent