SanaTos Multi Symptom

Product NDC
55758-361
11-digit product format
557580361
Labeler code
55758
Product ID
55758-361_3cf6f937-1511-460f-e063-6294a90abde7
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCI
Dosage form
TABLET
Route
ORAL
Labeler
Pharmadel LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-08-01
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 15; 200; 5 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SanaTos Multi Symptom
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE15 mg/1
GUAIFENESIN200 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
Rxcui1367204

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55758-361-02SanaTos Multi Symptom2 in 1 PACKETTABLET23
55758-361-99SanaTos Multi Symptom50 in 1 CARTONTABLET503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55758-361SANATOS MULTI SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI) TABLET [PHARMADEL LLC]2Current NDC, Legacy NDC, 2 package rows20241120_df260190-89e7-b338-e053-2995a90a32cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1367204acetaminophen 325 MG / dextromethorphan HBr 15 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSNdf260190-89e7-b338-e053-2995a90a32cb3
1367204acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDdf260190-89e7-b338-e053-2995a90a32cb3
1367204APAP 325 MG / dextromethorphan hydrobromide 15 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSYdf260190-89e7-b338-e053-2995a90a32cb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55758-361-02557580361022 TABLET in 1 PACKET (55758-361-02) 2 tablet2020-08-010000-00-00NoNoCurrent
55758-361-995575803619950 PACKET in 1 CARTON (55758-361-99) / 2 TABLET in 1 PACKET (55758-361-02) 50 packet2020-08-010000-00-00NoNoCurrent