Home NDC 54973-3315 Baby Oral Pain Relief
Product NDC 54973-3315
11-digit product format 549733315
Labeler code 54973
Product ID 54973-3315_2d83ba02-987c-b74b-e063-6294a90a6dc0
Type HUMAN OTC DRUG
Nonproprietary name oyster shell calcium carbonate, crude, tribasic calcium phosphate, arabica coffee bean, arnica montana, ferrum phosphoricum and matricaria chamomilla
Dosage form TABLET
Route ORAL
Labeler Hyland' Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2017-08-17
Substance ARABICA COFFEE BEAN; ARNICA MONTANA; FERRUM PHOSPHORICUM; MATRICARIA CHAMOMILLA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE
Active strength 6; 30; 12; 12; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
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 2026-12-31
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 · 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…
Additional Listing Data#
Finished product Yes
Brand name base Baby Oral Pain Relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OYSTER SHELL CALCIUM CARBONATE, CRUDE 6 [hp_X]/g TRIBASIC CALCIUM PHOSPHATE 30 [hp_X]/g ARABICA COFFEE BEAN 12 [hp_X]/g ARNICA MONTANA 12 [hp_X]/g MATRICARIA CHAMOMILLA 12 [hp_X]/g FERRUM PHOSPHORICUM 12 [hp_X]/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 6 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54973-3315-1 Baby Oral Pain Relief 1 in 1 CARTON TABLET 1 15 54973-3315-1 Baby Oral Pain Relief 125 g in 1 BOTTLE, PLASTIC TABLET 125 15 54973-3315-3 Baby Oral Pain Relief 6 g in 1 PACKET TABLET 6 15 54973-3315-7 Baby Oral Pain Relief 1 in 1 CARTON TABLET 1 15 54973-3315-7 Baby Oral Pain Relief 80 g in 1 BOTTLE, PLASTIC TABLET 80 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54973-3315 BABY ORAL PAIN RELIEF (OYSTER SHELL CALCIUM CARBONATE, CRUDE, TRIBASIC CALCIUM PHOSPHATE, ARABICA COFFEE BEAN, ARNICA MONTANA, FERRUM PHOSPHORICUM AND MATRICARIA CHAMOMILLA) TABLET [HYLAND' INC.] 15 Current NDC, Legacy NDC, 5 package rows 20250209_5904f126-e8f0-a892-e053-2991aa0aef0f.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Baby Oral Pain Relief OYSTER SHELL CALCIUM CARBONATE, CRUDE, TRIBASIC CALCIUM PHOSPHATE, ARABICA COFFEE BEAN, ARNICA MONTANA, FERRUM PHOSPHORICUM AND MATRICARIA CHAMOMILLA Hyland' Inc. 5904f126-e8f0-a892-e053-2991aa0aef0f 2025-02-06 Warnings Exact identifier ndc (product): 54973-3315
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54973-3315-1 54973331501 1 BOTTLE, PLASTIC in 1 CARTON (54973-3315-1) / 125 g in 1 BOTTLE, PLASTIC 2017-08-17 0000-00-00 No No Current 54973-3315-3 54973331503 6 g in 1 PACKET (54973-3315-3) 6 g 2017-08-17 0000-00-00 Yes No Current 54973-3315-7 54973331507 1 BOTTLE, PLASTIC in 1 CARTON (54973-3315-7) / 80 g in 1 BOTTLE, PLASTIC 2017-08-17 0000-00-00 No No Current