SanaTos
- Product NDC
- 55758-385
- 11-digit product format
- 557580385
- Labeler code
- 55758
- Product ID
- 55758-385_4873c00c-3edf-844a-e063-6394a90ac80d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Diphenhydramine hydrochloride, and Phenylephrine hydrochloride
- Dosage form
- GRANULE, FOR SOLUTION
- Route
- ORAL
- Labeler
- Pharmadel LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-03-31
- Substance
- ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 650; 25; 10 mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SanaTos
- Brand name suffix
- Severe Cold Relief Nighttime
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 650 mg/1 |
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, TC2D6JAD40, 04JA59TNSJ |
| Rxcui | 1659960 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55758-385-06 | SanaTosSevere Cold Relief Nighttime | 6 in 1 CARTON | GRANULE, FOR SOLUTION | 6 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55758-385 | SANATOS SEVERE COLD RELIEF NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) GRANULE, FOR SOLUTION [PHARMADEL LLC] | 7 | Current NDC, 1 package rows | 20240331_144aafcc-6ec2-a322-e063-6294a90afc27.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 55758-385-06 | 55758038506 | 6 GRANULE, FOR SOLUTION in 1 CARTON (55758-385-06) | 2024-03-31 | No | No | Historical |