4 Kids Earache Relief
- Product NDC
- 54973-3393
- 11-digit product format
- 549733393
- Labeler code
- 54973
- Product ID
- 54973-3393_ee178924-32b4-b5f4-e053-2995a90a6a07
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- MATRICARIA CHAMOMILLA,FERRIC PHOSPHATE,SULFUR,OYSTER SHELL CALCIUM CARBONATE, CRUDE,LYCOPODIUM CLAVATUM SPORE and ANEMONE PULSATILLA
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Hyland's Inc.
- Marketing category
- UNAPPROVED HOMEOPATHIC
- Marketing start
- 2018-12-01
- Marketing end
- 0000-00-00
- Substance
- ANEMONE PULSATILLA; FERROSOFERRIC PHOSPHATE; LYCOPODIUM CLAVATUM SPORE; MATRICARIA CHAMOMILLA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SULFUR
- Active strength
- 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 54973-3393 | D | Discontinued by firm | 2026-10-12 | ||
| excluded package | package | 54973-3393 | 54973-3393-1 | D | Discontinued by firm | 2026-10-12 |
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.
| 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 | 54973-3393-1 | 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 | 54973-3393-1 | f5e01cc5f278… | a2eaf40c39c3… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 54973-3393-1 | 54973339301 | 1 BOTTLE, PLASTIC in 1 CARTON (54973-3393-1) > 40 TABLET in 1 BOTTLE, PLASTIC | 2018-12-01 | 0000-00-00 | No | No | Current |