FDA.reportPublic FDA data

Belladonna and Opium

Product NDC
0574-7040
11-digit product format
005747040
Labeler code
0574
Product ID
0574-7040_7b45a1d7-c3a5-4434-a848-45638cedd6e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATROPA BELLADONNA and OPIUM
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Padagis US LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1997-04-22
Substance
ATROPA BELLADONNA; OPIUM
Active strength
16.2; 60 mg/1; mg/1
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
Belladonna and Opium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATROPA BELLADONNA16.2 mg/1
OPIUM60 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WQZ3G9PF0HInternal UNII lookup
37M3MZ001LInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312104Internal RxNorm lookup
312107Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8301e76b-134a-43d2-a7dc-c600ccf2695cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0574-7040-04Belladonna and Opium1 in 1 PACKETSUPPOSITORY110
0574-7040-04Belladonna and Opium4 in 1 BOXSUPPOSITORY410
0574-7040-12Belladonna and Opium1 in 1 PACKETSUPPOSITORY110
0574-7040-12Belladonna and Opium12 in 1 BOXSUPPOSITORY1210

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0574-7040-04EA - Each0574-7040ab159889-0ebe-4ca8-b2de-4a619efaf0eb12019-04-11
0574-7040-12EA - Each0574-704025733d35-3a15-4c1c-a099-cbb4294077f512013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0HBELLADONNA AND OPIUM (ATROPA BELLADONNA AND OPIUM) SUPPOSITORY [PADDOCK LABORATORIES, LLC]1
OPIUMACTIVE INGREDIENT37M3MZ001LBELLADONNA AND OPIUM (ATROPA BELLADONNA AND OPIUM) SUPPOSITORY [PADDOCK LABORATORIES, LLC]1
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0HBELLADONNA AND OPIUM (ATROPA BELLADONNA AND OPIUM) SUPPOSITORY [PADDOCK LABORATORIES, LLC]1
OPIUMACTIVE MOIETY37M3MZ001LBELLADONNA AND OPIUM (ATROPA BELLADONNA AND OPIUM) SUPPOSITORY [PADDOCK LABORATORIES, LLC]1
POLYETHYLENE GLYCOL 1450INACTIVE INGREDIENTOJ4Z5Z32L4BELLADONNA AND OPIUM (ATROPA BELLADONNA AND OPIUM) SUPPOSITORY [PADDOCK LABORATORIES, LLC]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQBELLADONNA AND OPIUM (ATROPA BELLADONNA AND OPIUM) SUPPOSITORY [PADDOCK LABORATORIES, LLC]1
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BBELLADONNA AND OPIUM (ATROPA BELLADONNA AND OPIUM) SUPPOSITORY [PADDOCK LABORATORIES, LLC]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MBELLADONNA AND OPIUM (ATROPA BELLADONNA AND OPIUM) SUPPOSITORY [PADDOCK LABORATORIES, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0574-7040BELLADONNA AND OPIUM (ATROPA BELLADONNA AND OPIUM) SUPPOSITORY [PADAGIS US LLC]10Current NDC, Legacy NDC, 4 package rows20240426_8301e76b-134a-43d2-a7dc-c600ccf2695c.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
Belladonna and OpiumATROPA BELLADONNA AND OPIUMPadagis US LLC8301e76b-134a-43d2-a7dc-c600ccf2695c2023-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (product): 0574-7040

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312104belladonna 16.2 MG / opium 30 MG Rectal SuppositoryPSN8301e76b-134a-43d2-a7dc-c600ccf2695c10
312107belladonna 16.2 MG / opium 60 MG Rectal SuppositoryPSN8301e76b-134a-43d2-a7dc-c600ccf2695c10
312104belladonna alkaloids 16.2 MG / opium 30 MG Rectal SuppositorySCD8301e76b-134a-43d2-a7dc-c600ccf2695c10
312107belladonna alkaloids 16.2 MG / opium 60 MG Rectal SuppositorySCD8301e76b-134a-43d2-a7dc-c600ccf2695c10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0574-7040-04005747040044 PACKET in 1 BOX (0574-7040-04) / 1 SUPPOSITORY in 1 PACKET4 packet2018-08-220000-00-00NoNoCurrent
0574-7040-120057470401212 PACKET in 1 BOX (0574-7040-12) / 1 SUPPOSITORY in 1 PACKET12 packet1997-04-220000-00-00NoNoCurrent