Awaken
- Product NDC
- 54973-3333
- Requested package NDC
- 54973-3333-1
- 11-digit product format
- 549733333
- Labeler code
- 54973
- Product ID
- 54973-3333_ee8c77fe-b88a-4168-e053-2a95a90a7cd0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- DAPHNE MEZEREUM BARK,SULFUR,DELPHINIUM STAPHISAGRIA SEED,SEPIA OFFICINALIS JUICE,SODIUM CHLORIDE,PHOSPHORIC ACID,DIBASIC POTASSIUM PHOSPHATE and THUJA OCCIDENTALIS LEAFY TWIG
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Hyland's Inc.
- Marketing category
- UNAPPROVED HOMEOPATHIC
- Marketing start
- 2017-12-01
- Marketing end
- 0000-00-00
- Substance
- DAPHNE MEZEREUM BARK; DELPHINIUM STAPHISAGRIA SEED; DIBASIC POTASSIUM PHOSPHATE; PHOSPHORIC ACID; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG
- Active strength
- 12 [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
- Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]
- 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 package | package | 54973-3333 | 54973-3333-1 | D | Discontinued by firm | 2026-10-05 |
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 | 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 | 54973-3333 | 54973-3333-1 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 54973-3333 | 54973-3333-1 | 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.
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 54973-3333-1 | 54973333301 | 1 BOTTLE, PLASTIC in 1 CARTON (54973-3333-1) > 50 TABLET in 1 BOTTLE, PLASTIC | 2017-12-01 | 0000-00-00 | No | No | Current |