FDA.reportPublic FDA data

Rescue Sleep Pastilles Blackcurrant

Product NDC
57687-320
11-digit product format
576870320
Labeler code
57687
Product ID
57687-320_4cea6b57-588b-2e55-e063-6394a90a093a
Type
HUMAN OTC DRUG
Nonproprietary name
Rescue Sleep Pastilles Blackcurrant
Dosage form
LOZENGE
Route
ORAL
Labeler
Nelson Bach USA Ltd
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2024-06-28
Substance
AESCULUS HIPPOCASTANUM FLOWER; CLEMATIS VITALBA PRE-FLOWERING TOP; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM; PRUNUS CERASIFERA FLOWER
Active strength
5; 5; 5; 5; 5; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rescue Sleep Pastilles Blackcurrant
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HELIANTHEMUM NUMMULARIUM FLOWER5 [hp_X]/1
ORNITHOGALUM UMBELLATUM5 [hp_X]/1
IMPATIENS GLANDULIFERA FLOWER5 [hp_X]/1
AESCULUS HIPPOCASTANUM FLOWER5 [hp_X]/1
CLEMATIS VITALBA PRE-FLOWERING TOP5 [hp_X]/1
PRUNUS CERASIFERA FLOWER5 [hp_X]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
51BRR32WPPInternal UNII lookup
9NS3M2Y78SInternal UNII lookup
AJU5O1A5ZVInternal UNII lookup
KK0Z92II8MInternal UNII lookup
490F0009OPInternal UNII lookup
0KD7R09EASInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1ba628e9-6abd-89a1-e063-6394a90aa5bcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57687-320-50Rescue Sleep Pastilles Blackcurrant35 in 1 CONTAINERLOZENGE352

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57687-320RESCUE SLEEP PASTILLES BLACKCURRANT LOZENGE [NELSON BACH USA LTD]1Current NDC, 1 package rows20240628_1ba628e9-6abd-89a1-e063-6394a90aa5bc.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
Rescue Sleep Pastilles BlackcurrantRESCUE SLEEP PASTILLES BLACKCURRANTNelson Bach USA Ltd1ba628e9-6abd-89a1-e063-6394a90aa5bc2026-03-13WarningsExact identifier
ndc (product): 57687-320

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57687-320-505768703205035 LOZENGE in 1 CONTAINER (57687-320-50) 35 lozenge2024-06-28NoNoCurrent