Distress Drops

Product NDC
63083-2121
11-digit product format
630832121
Labeler code
63083
Product ID
63083-2121_2aaef7a8-fe3f-42ab-9f8a-f125b590014b
Type
HUMAN OTC DRUG
Nonproprietary name
Distress Drops
Dosage form
LIQUID
Route
ORAL
Labeler
Professional Complementary Health Formulas
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1984-08-15
Substance
AVENA SATIVA FLOWERING TOP; CICUTA VIROSA WHOLE; DELPHINIUM STAPHISAGRIA SEED; DICENTRA CANADENSIS ROOT; FERULA ASSA-FOETIDA RESIN; FERULA SUMBUL ROOT; GAULTHERIA PROCUMBENS TOP; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; VALERIAN
Active strength
1; 4; 4; 3; 3; 6; 4; 3; 4; 3 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Distress Drops
Brand name suffix
2121
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVENA SATIVA FLOWERING TOP1 [hp_X]/59mL
CICUTA VIROSA WHOLE4 [hp_X]/59mL
DELPHINIUM STAPHISAGRIA SEED4 [hp_X]/59mL
DICENTRA CANADENSIS ROOT3 [hp_X]/59mL
FERULA ASSA-FOETIDA RESIN3 [hp_X]/59mL
FERULA SUMBUL ROOT6 [hp_X]/59mL
GAULTHERIA PROCUMBENS TOP4 [hp_X]/59mL
HYOSCYAMUS NIGER3 [hp_X]/59mL
STRYCHNOS IGNATII SEED4 [hp_X]/59mL
VALERIAN3 [hp_X]/59mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMA9CQJ3F7F, 3E698BL84C, 00543AP1JV, Y5JS7YM46F, W9FZA51AS1, GLA4808EHQ, 830295X963, 4WRK2153H3, 1NM3M2487K, JWF5YAW3QW

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63083-2121-22026-01-08C16284748780-11030e365-4b4f-111a-e063-dadaa90a10e2C121
63083-2121-22026-01-08C16284748780-11030e365-4b4f-111a-e063-dadaa90a10e2C121
63083-2121-22024-01-30C16284748780-11030e365-4b4f-111a-e063-dadaa90a10e2C121
63083-2121-22024-01-30C16284748780-11030e365-4b4f-111a-e063-dadaa90a10e2C121

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63083-2121-2Distress Drops212159 mL in 1 BOTTLE, DROPPERLIQUID592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63083-2121DISTRESS DROPS 2121 (DISTRESS DROPS) LIQUID [PROFESSIONAL COMPLEMENTARY HEALTH FORMULAS]1Current NDC, Legacy NDC, 1 package rows20220215_901dfa0f-343b-4385-8b25-7e41a1a7cd1d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63083-2121-26308321210259 mL in 1 BOTTLE, DROPPER (63083-2121-2) 59 ml1985-08-150000-00-00NoNoCurrent