Home NDC 57955-5638-2 Sleep Aid
Product NDC 57955-5638
Requested package NDC 57955-5638-2
11-digit product format 579555638
Labeler code 57955
Product ID 57955-5638_defa9438-5676-40e8-9a13-7d0035c3a989
Type HUMAN OTC DRUG
Nonproprietary name Aconitum napellus, Aesculus hippocastanum, flos, Arsenicum album, Avena sativa, Belladonna, Camphora, Cinchona officinalis, Coffea cruda, Cypripedium pubescens, Hyoscyamus niger, Kali phosphoricum, Ignatia amara, Passiflora incarnata, Phosphorus, Pulsatilla, Valeriana officinalis.
Dosage form LIQUID
Route ORAL
Labeler King Bio Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2022-08-16
Marketing end 0000-00-00
Substance ACONITUM NAPELLUS WHOLE; AESCULUS HIPPOCASTANUM FLOWER; ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; ATROPA BELLADONNA; AVENA SATIVA FLOWERING TOP; CAMPHOR (NATURAL); CINCHONA OFFICINALIS BARK; CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT; DIBASIC POTASSIUM PHOSPHATE; HYOSCYAMUS NIGER; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PULSATILLA VULGARIS WHOLE; STRYCHNOS IGNATII SEED; VALERIAN
Active strength 10 [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; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL
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 2023-12-31
Current FDA listing Historical FDA.report record 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 57955-5638 57955-5638-2 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 57955-5638 57955-5638-2 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57955-5638 SLEEP AID (ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, FLOS, ARSENICUM ALBUM, AVENA SATIVA, BELLADONNA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSCYAMUS NIGER, KALI PHOSPHORICUM, IGNATIA AMARA, PASSIFLORA INCARNATA, PHOSPHORUS, PULSATILLA, VALERIANA OFFICINALIS.) LIQUID [KING BIO INC.] 3 Legacy NDC 20250524_44daeef5-1e4d-474e-ae60-1131c15e470e.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 57955-5638-2 57955563802 1 BOTTLE, SPRAY in 1 CARTON (57955-5638-2) > 59 mL in 1 BOTTLE, SPRAY 2022-08-16 0000-00-00 No No Current