FDA.reportPublic FDA data

Real Relief

Product NDC
63388-989
11-digit product format
633880989
Labeler code
63388
Product ID
63388-989_40aab33d-ed77-de31-e063-6294a90aa48d
Type
HUMAN OTC DRUG
Nonproprietary name
DROSERA, ARNICA MONTANA, BRYONIA, IPECACUANHA, CETRARIA ISLANDICA, COCCUS CACTI, CORALLIUM RUBRUM, STANNUM METALLICUM, CAMOMILLA, COFFEA CRUDEA
Dosage form
LIQUID
Route
ORAL
Labeler
Laboratoire Atlas Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2018-05-03
Substance
ARABICA COFFEE BEAN; ARNICA MONTANA; BRYONIA ALBA WHOLE; CETRARIA ISLANDICA SUBSP. ISLANDICA; CHAMOMILE; CORALLIUM RUBRUM WHOLE; DROSERA ROTUNDIFOLIA FLOWERING TOP; IPECAC; PROTORTONIA CACTI; TIN
Active strength
4; 3; 3; 1; 4; 3; 1; 3; 3; 3 [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Real Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DROSERA ROTUNDIFOLIA FLOWERING TOP1 [hp_C]/100mL
ARNICA MONTANA3 [hp_C]/100mL
BRYONIA ALBA WHOLE3 [hp_C]/100mL
IPECAC3 [hp_C]/100mL
CETRARIA ISLANDICA SUBSP. ISLANDICA1 [hp_C]/100mL
PROTORTONIA CACTI3 [hp_C]/100mL
CORALLIUM RUBRUM WHOLE3 [hp_C]/100mL
TIN3 [hp_C]/100mL
CHAMOMILE4 [hp_C]/100mL
ARABICA COFFEE BEAN4 [hp_C]/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
75O014T1HGInternal UNII lookup
O80TY208ZWInternal UNII lookup
56K0VVT47PInternal UNII lookup
62I3C8233LInternal UNII lookup
BJ7YPN79A1Internal UNII lookup
LZB7TFX1LTInternal UNII lookup
22Z32PWR7RInternal UNII lookup
387GMG9FH5Internal UNII lookup
FGL3685T2XInternal UNII lookup
3SW678MX72Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fe18547a-0212-4cdf-accd-566ef122ff27Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63388-989-49Real Relief1 in 1 CARTONLIQUID15
63388-989-49Real Relief250 mL in 1 BOTTLELIQUID2505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63388-989REAL RELIEF (DROSERA, ARNICA MONTANA, BRYONIA, IPECACUANHA, CETRARIA ISLANDICA, COCCUS CACTI, CORALLIUM RUBRUM, STANNUM METALLICUM, CAMOMILLA, COFFEA CRUDEA) LIQUID [LABORATOIRE ATLAS INC]4Current NDC, Legacy NDC, 2 package rows20241127_fe18547a-0212-4cdf-accd-566ef122ff27.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
Real ReliefDROSERA, ARNICA MONTANA, BRYONIA, IPECACUANHA, CETRARIA ISLANDICA, COCCUS CACTI, CORALLIUM RUBRUM, STANNUM METALLICUM, CAMOMILLA, COFFEA CRUDEALaboratoire Atlas Incfe18547a-0212-4cdf-accd-566ef122ff272025-10-08WarningsExact identifier
ndc (product): 63388-989

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63388-989-49633880989491 BOTTLE in 1 CARTON (63388-989-49) / 250 mL in 1 BOTTLE1 bottle2018-05-030000-00-00NoNoCurrent