Home NDC 53145-006 Defensolito
Product NDC 53145-006
11-digit product format 531450006
Labeler code 53145
Product ID 53145-006_6c393469-4661-48e4-89e0-8414b8ee010c
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Phenylephrine Hydrochloride
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Menper Distributors, Inc.
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2012-02-21
Marketing end 0000-00-00
Substance ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 80 mg/1; mg/1
NDC exclude flag E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record 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.
Historic NDC status page 1 of 1 · 21 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 53145-006-30 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 53145-006-02 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 53145-006-30 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 53145-006-02 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 53145-006-30 I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 53145-006-02 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 53145-006-30 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 53145-006-02 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53145-006-30 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53145-006-02 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53145-006-30 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53145-006-02 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 53145-006-02 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 53145-006-30 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 Status 53145-006-02 53145000602 50 in 1 CARTON Historical 53145-006-30 53145000630 30 in 1 BOTTLE Historical