Home NDC 54973-1120 CALMS NERVE TENSION SLEEPLESSNESS
Product NDC 54973-1120
11-digit product format 549731120
Labeler code 54973
Product ID 54973-1120_ef43098f-998a-7001-e053-2995a90aa820
Type HUMAN OTC DRUG
Nonproprietary name passiflora incarnata flower, avena sativa leaf, hops, and chamomile
Dosage form TABLET
Route ORAL
Labeler Hyland's Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 1980-01-01
Marketing end 0000-00-00
Substance AVENA SATIVA LEAF; CHAMOMILE; HOPS; PASSIFLORA INCARNATA FLOWER
Active strength 1 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant 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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 54973-1120-3 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 54973-1120-3 f5e01cc5f278…a2eaf40c39c3…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AVENA SATIVA LEAF ACTIVE INGREDIENT 206PI19V7R CALMS NERVE TENSION SLEEPLESSNESS (PASSIFLORA INCARNATA FLOWER, AVENA SATIVA LEAF, HOPS, AND CHAMOMILE) TABLET [HYLAND'S] 1 CHAMOMILE ACTIVE INGREDIENT FGL3685T2X CALMS NERVE TENSION SLEEPLESSNESS (PASSIFLORA INCARNATA FLOWER, AVENA SATIVA LEAF, HOPS, AND CHAMOMILE) TABLET [HYLAND'S] 1 HOPS ACTIVE INGREDIENT 01G73H6H83 CALMS NERVE TENSION SLEEPLESSNESS (PASSIFLORA INCARNATA FLOWER, AVENA SATIVA LEAF, HOPS, AND CHAMOMILE) TABLET [HYLAND'S] 1 PASSIFLORA INCARNATA FLOWER ACTIVE INGREDIENT K8F3G29S6Z CALMS NERVE TENSION SLEEPLESSNESS (PASSIFLORA INCARNATA FLOWER, AVENA SATIVA LEAF, HOPS, AND CHAMOMILE) TABLET [HYLAND'S] 1 AVENA SATIVA LEAF ACTIVE MOIETY 206PI19V7R CALMS NERVE TENSION SLEEPLESSNESS (PASSIFLORA INCARNATA FLOWER, AVENA SATIVA LEAF, HOPS, AND CHAMOMILE) TABLET [HYLAND'S] 1 CHAMOMILE ACTIVE MOIETY FGL3685T2X CALMS NERVE TENSION SLEEPLESSNESS (PASSIFLORA INCARNATA FLOWER, AVENA SATIVA LEAF, HOPS, AND CHAMOMILE) TABLET [HYLAND'S] 1 HOPS ACTIVE MOIETY 01G73H6H83 CALMS NERVE TENSION SLEEPLESSNESS (PASSIFLORA INCARNATA FLOWER, AVENA SATIVA LEAF, HOPS, AND CHAMOMILE) TABLET [HYLAND'S] 1 PASSIFLORA INCARNATA FLOWER ACTIVE MOIETY K8F3G29S6Z CALMS NERVE TENSION SLEEPLESSNESS (PASSIFLORA INCARNATA FLOWER, AVENA SATIVA LEAF, HOPS, AND CHAMOMILE) TABLET [HYLAND'S] 1 LACTOSE INACTIVE INGREDIENT J2B2A4N98G CALMS NERVE TENSION SLEEPLESSNESS (PASSIFLORA INCARNATA FLOWER, AVENA SATIVA LEAF, HOPS, AND CHAMOMILE) TABLET [HYLAND'S] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CALMS NERVE TENSION SLEEPLESSNESS (PASSIFLORA INCARNATA FLOWER, AVENA SATIVA LEAF, HOPS, AND CHAMOMILE) TABLET [HYLAND'S] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CALMS NERVE TENSION SLEEPLESSNESS (PASSIFLORA INCARNATA FLOWER, AVENA SATIVA LEAF, HOPS, AND CHAMOMILE) TABLET [HYLAND'S] 1 STARCH, TAPIOCA INACTIVE INGREDIENT 24SC3U704I CALMS NERVE TENSION SLEEPLESSNESS (PASSIFLORA INCARNATA FLOWER, AVENA SATIVA LEAF, HOPS, AND CHAMOMILE) TABLET [HYLAND'S] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 54973-1120-3 54973112003 1 BOTTLE, PLASTIC in 1 CARTON (54973-1120-3) > 100 TABLET in 1 BOTTLE, PLASTIC 1980-01-01 0000-00-00 No No Current