Home NDC 63083-2121-2 Distress Drops
Product NDC 63083-2121
Requested package NDC 63083-2121-2
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; FERULA ASSA-FOETIDA RESIN; DICENTRA CANADENSIS ROOT; HYOSCYAMUS NIGER; FERULA SUMBUL ROOT; VALERIAN; CICUTA VIROSA WHOLE; STRYCHNOS IGNATII SEED; GAULTHERIA PROCUMBENS TOP; DELPHINIUM STAPHISAGRIA SEED
Active strength 1; 3; 3; 3; 6; 3; 4; 4; 4; 4 [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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 Ingredient Strength AVENA SATIVA FLOWERING TOP 1 [hp_X]/59mL FERULA ASSA-FOETIDA RESIN 3 [hp_X]/59mL DICENTRA CANADENSIS ROOT 3 [hp_X]/59mL HYOSCYAMUS NIGER 3 [hp_X]/59mL FERULA SUMBUL ROOT 6 [hp_X]/59mL VALERIAN 3 [hp_X]/59mL CICUTA VIROSA WHOLE 4 [hp_X]/59mL STRYCHNOS IGNATII SEED 4 [hp_X]/59mL GAULTHERIA PROCUMBENS TOP 4 [hp_X]/59mL DELPHINIUM STAPHISAGRIA SEED 4 [hp_X]/59mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 10 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# Effective, Related label table Effective Related label 2026-01-08 C121 2026-01-08 C121 2024-01-30 C121 2024-01-30 C121
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63083-2121-2 Distress Drops2121 59 mL in 1 BOTTLE, DROPPER LIQUID 59 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63083-2121 DISTRESS DROPS 2121 (DISTRESS DROPS) LIQUID [PROFESSIONAL COMPLEMENTARY HEALTH FORMULAS] 1 Current NDC, Legacy NDC, 1 package rows 20220215_901dfa0f-343b-4385-8b25-7e41a1a7cd1d.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63083-2121-2 63083212102 59 mL in 1 BOTTLE, DROPPER (63083-2121-2) 59 ml 1985-08-15 0000-00-00 No No Current