Home NDC 54973-3161-1 CALM N RESTFUL 4 KIDS
Product NDC 54973-3161
Requested package NDC 54973-3161-1
11-digit product format 549733161
Labeler code 54973
Product ID 54973-3161_ef42e598-59ea-a7e2-e053-2a95a90a33e9
Type HUMAN OTC DRUG
Nonproprietary name aconitum napellus root, calcium phosphate, chamomile, artemisia cina pre-flowering top, lycopodium clavatum spore, sodium chloride, pulsatilla vulgaris, and sulfur
Dosage form TABLET
Route ORAL
Labeler Hyland's Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2013-06-10
Marketing end 0000-00-00
Substance ACONITUM NAPELLUS ROOT; ARTEMISIA CINA PRE-FLOWERING TOP; CALCIUM PHOSPHATE; CHAMOMILE; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SODIUM CHLORIDE; SULFUR
Active strength 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
Pharmacologic classes Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]
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 · 12 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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACONITUM NAPELLUS ROOT ACTIVE INGREDIENT KPD2N7348X CALM N RESTFUL 4 KIDS (ACONITUM NAPELLUS ROOT, CALCIUM PHOSPHATE, CHAMOMILE, ARTEMISIA CINA PRE-FLOWERING TOP, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, PULSATILLA VULGARIS, AND SULFUR) TABLET [HYLAND'S] 1 ARTEMISIA CINA PRE-FLOWERING TOP ACTIVE INGREDIENT 28M1820ACT CALM N RESTFUL 4 KIDS (ACONITUM NAPELLUS ROOT, CALCIUM PHOSPHATE, CHAMOMILE, ARTEMISIA CINA PRE-FLOWERING TOP, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, PULSATILLA VULGARIS, AND SULFUR) TABLET [HYLAND'S] 1 CALCIUM PHOSPHATE ACTIVE INGREDIENT 97Z1WI3NDX CALM N RESTFUL 4 KIDS (ACONITUM NAPELLUS ROOT, CALCIUM PHOSPHATE, CHAMOMILE, ARTEMISIA CINA PRE-FLOWERING TOP, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, PULSATILLA VULGARIS, AND SULFUR) TABLET [HYLAND'S] 1 CHAMOMILE ACTIVE INGREDIENT FGL3685T2X CALM N RESTFUL 4 KIDS (ACONITUM NAPELLUS ROOT, CALCIUM PHOSPHATE, CHAMOMILE, ARTEMISIA CINA PRE-FLOWERING TOP, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, PULSATILLA VULGARIS, AND SULFUR) TABLET [HYLAND'S] 1 LYCOPODIUM CLAVATUM SPORE ACTIVE INGREDIENT C88X29Y479 CALM N RESTFUL 4 KIDS (ACONITUM NAPELLUS ROOT, CALCIUM PHOSPHATE, CHAMOMILE, ARTEMISIA CINA PRE-FLOWERING TOP, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, PULSATILLA VULGARIS, AND SULFUR) TABLET [HYLAND'S] 1 PULSATILLA VULGARIS ACTIVE INGREDIENT I76KB35JEV CALM N RESTFUL 4 KIDS (ACONITUM NAPELLUS ROOT, CALCIUM PHOSPHATE, CHAMOMILE, ARTEMISIA CINA PRE-FLOWERING TOP, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, PULSATILLA VULGARIS, AND SULFUR) TABLET [HYLAND'S] 1 SODIUM CHLORIDE ACTIVE INGREDIENT 451W47IQ8X CALM N RESTFUL 4 KIDS (ACONITUM NAPELLUS ROOT, CALCIUM PHOSPHATE, CHAMOMILE, ARTEMISIA CINA PRE-FLOWERING TOP, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, PULSATILLA VULGARIS, AND SULFUR) TABLET [HYLAND'S] 1 SULFUR ACTIVE INGREDIENT 70FD1KFU70 CALM N RESTFUL 4 KIDS (ACONITUM NAPELLUS ROOT, CALCIUM PHOSPHATE, CHAMOMILE, ARTEMISIA CINA PRE-FLOWERING TOP, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, PULSATILLA VULGARIS, AND SULFUR) TABLET [HYLAND'S] 1 ACONITUM NAPELLUS ROOT ACTIVE MOIETY KPD2N7348X CALM N RESTFUL 4 KIDS (ACONITUM NAPELLUS ROOT, CALCIUM PHOSPHATE, CHAMOMILE, ARTEMISIA CINA PRE-FLOWERING TOP, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, PULSATILLA VULGARIS, AND SULFUR) TABLET [HYLAND'S] 1 ARTEMISIA CINA PRE-FLOWERING TOP ACTIVE MOIETY 28M1820ACT CALM N RESTFUL 4 KIDS (ACONITUM NAPELLUS ROOT, CALCIUM PHOSPHATE, CHAMOMILE, ARTEMISIA CINA PRE-FLOWERING TOP, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, PULSATILLA VULGARIS, AND SULFUR) TABLET [HYLAND'S] 1 CALCIUM CATION ACTIVE MOIETY 2M83C4R6ZB CALM N RESTFUL 4 KIDS (ACONITUM NAPELLUS ROOT, CALCIUM PHOSPHATE, CHAMOMILE, ARTEMISIA CINA PRE-FLOWERING TOP, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, PULSATILLA VULGARIS, AND SULFUR) TABLET [HYLAND'S] 1 CHAMOMILE ACTIVE MOIETY FGL3685T2X CALM N RESTFUL 4 KIDS (ACONITUM NAPELLUS ROOT, CALCIUM PHOSPHATE, CHAMOMILE, ARTEMISIA CINA PRE-FLOWERING TOP, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, PULSATILLA VULGARIS, AND SULFUR) TABLET [HYLAND'S] 1 CHLORIDE ION ACTIVE MOIETY Q32ZN48698 CALM N RESTFUL 4 KIDS (ACONITUM NAPELLUS ROOT, CALCIUM PHOSPHATE, CHAMOMILE, ARTEMISIA CINA PRE-FLOWERING TOP, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, PULSATILLA VULGARIS, AND SULFUR) TABLET [HYLAND'S] 1 LYCOPODIUM CLAVATUM SPORE ACTIVE MOIETY C88X29Y479 CALM N RESTFUL 4 KIDS (ACONITUM NAPELLUS ROOT, CALCIUM PHOSPHATE, CHAMOMILE, ARTEMISIA CINA PRE-FLOWERING TOP, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, PULSATILLA VULGARIS, AND SULFUR) TABLET [HYLAND'S] 1 PULSATILLA VULGARIS ACTIVE MOIETY I76KB35JEV CALM N RESTFUL 4 KIDS (ACONITUM NAPELLUS ROOT, CALCIUM PHOSPHATE, CHAMOMILE, ARTEMISIA CINA PRE-FLOWERING TOP, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, PULSATILLA VULGARIS, AND SULFUR) TABLET [HYLAND'S] 1 SULFUR ACTIVE MOIETY 70FD1KFU70 CALM N RESTFUL 4 KIDS (ACONITUM NAPELLUS ROOT, CALCIUM PHOSPHATE, CHAMOMILE, ARTEMISIA CINA PRE-FLOWERING TOP, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, PULSATILLA VULGARIS, AND SULFUR) TABLET [HYLAND'S] 1 ACACIA INACTIVE INGREDIENT 5C5403N26O CALM N RESTFUL 4 KIDS (ACONITUM NAPELLUS ROOT, CALCIUM PHOSPHATE, CHAMOMILE, ARTEMISIA CINA PRE-FLOWERING TOP, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, PULSATILLA VULGARIS, AND SULFUR) TABLET [HYLAND'S] 1 LACTOSE INACTIVE INGREDIENT J2B2A4N98G CALM N RESTFUL 4 KIDS (ACONITUM NAPELLUS ROOT, CALCIUM PHOSPHATE, CHAMOMILE, ARTEMISIA CINA PRE-FLOWERING TOP, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, PULSATILLA VULGARIS, AND SULFUR) 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 54973-3161-1 54973316101 1 BOTTLE, PLASTIC in 1 CARTON (54973-3161-1) > 125 TABLET in 1 BOTTLE, PLASTIC 2013-06-10 0000-00-00 No No Current