Defensolito
- Product NDC
- 53145-006
- 11-digit product format
- 531450006
- Labeler code
- 53145
- Product ID
- 53145-006_3a875ad3-8a76-b446-e063-6294a90a1a63
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Phenylephrine Hydrochloride
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Menper Distributors, Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2012-02-21
- Substance
- ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 80; 2.5 mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [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
- Defensolito
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 80 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 04JA59TNSJ |
| Rxcui | 1539545 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53145-006-02 | Defensolito | 50 in 1 CARTON | TABLET, CHEWABLE | 50 | | 4 |
| 53145-006-02 | Defensolito | 2 in 1 PACKET | TABLET, CHEWABLE | 2 | | 4 |
| 53145-006-30 | Defensolito | 30 in 1 BOTTLE | TABLET, CHEWABLE | 30 | | 4 |
| 53145-006-30 | Defensolito | 1 in 1 BOX | TABLET, CHEWABLE | 1 | | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | DEFENSOLITO (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, CHEWABLE [MENPER DISTRIBUTORS, INC.] | 1 | |
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | DEFENSOLITO (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, CHEWABLE [MENPER DISTRIBUTORS, INC.] | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | DEFENSOLITO (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, CHEWABLE [MENPER DISTRIBUTORS, INC.] | 1 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | DEFENSOLITO (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, CHEWABLE [MENPER DISTRIBUTORS, INC.] | 1 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | DEFENSOLITO (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, CHEWABLE [MENPER DISTRIBUTORS, INC.] | 1 | |
| CARBOXYMETHYLCELLULOSE SODIUM | INACTIVE INGREDIENT | K679OBS311 | DEFENSOLITO (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, CHEWABLE [MENPER DISTRIBUTORS, INC.] | 1 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | DEFENSOLITO (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, CHEWABLE [MENPER DISTRIBUTORS, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DEFENSOLITO (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, CHEWABLE [MENPER DISTRIBUTORS, INC.] | 1 | |
| POLYVINYL ACETATE PHTHALATE | INACTIVE INGREDIENT | 58QVG85GW3 | DEFENSOLITO (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, CHEWABLE [MENPER DISTRIBUTORS, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | DEFENSOLITO (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, CHEWABLE [MENPER DISTRIBUTORS, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | DEFENSOLITO (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, CHEWABLE [MENPER DISTRIBUTORS, INC.] | 1 | |
| SUGARCANE | INACTIVE INGREDIENT | 81H2R5AOH3 | DEFENSOLITO (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, CHEWABLE [MENPER DISTRIBUTORS, INC.] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DEFENSOLITO (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, CHEWABLE [MENPER DISTRIBUTORS, INC.] | 1 | |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 53145-006-02 | 53145000602 | 50 PACKET in 1 CARTON (53145-006-02) / 2 TABLET, CHEWABLE in 1 PACKET | 50 packet | 2012-02-21 | No | No | Historical |
| 53145-006-30 | 53145000630 | 1 BOTTLE in 1 BOX (53145-006-30) / 30 TABLET, CHEWABLE in 1 BOTTLE | 1 bottle | 2012-02-21 | No | No | Historical |