XL3 XTRA

Product NDC
69772-440
11-digit product format
697720440
Labeler code
69772
Product ID
69772-440_1cbb8491-6ef8-45af-e054-00144ff88e88
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen chloepheniramine maleate dextromethorphan phenylepherine hydrochloride capsule liquid filled
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Teresa Cecena DBA Genesis
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-08-07
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE
Active strength
10 mg/mg; mg/mg; mg/mg; mg/mg
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
377068df-225f-7318-a910-a1987cdfa361Product name320170608
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69772-440-012020-01-31C16284748780-19d75b9d1-28e3-f424-e053-dadaa90a57ce1cbb8491-6ef7-45af-e054-00144ff88e88
69772-440-022020-01-31C16284748780-19d75b9d1-28e3-f424-e053-dadaa90a57ce1cbb8491-6ef7-45af-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69772-440-01XL3 XTRA20 mg in 1 BLISTER PACKCAPSULE, LIQUID FILLED201
69772-440-02XL3 XTRA12 mg in 1 BLISTER PACKCAPSULE, LIQUID FILLED121

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DXL3 XTRA (ACETAMINOPHEN CHLOEPHENIRAMINE MALEATE DEXTROMETHORPHAN PHENYLEPHERINE HYDROCHLORIDE CAPSULE LIQUID FILLED) CAPSULE, LIQUID FILLED [TERESA CECENA DBA GENESIS]1
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZXL3 XTRA (ACETAMINOPHEN CHLOEPHENIRAMINE MALEATE DEXTROMETHORPHAN PHENYLEPHERINE HYDROCHLORIDE CAPSULE LIQUID FILLED) CAPSULE, LIQUID FILLED [TERESA CECENA DBA GENESIS]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHXL3 XTRA (ACETAMINOPHEN CHLOEPHENIRAMINE MALEATE DEXTROMETHORPHAN PHENYLEPHERINE HYDROCHLORIDE CAPSULE LIQUID FILLED) CAPSULE, LIQUID FILLED [TERESA CECENA DBA GENESIS]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJXL3 XTRA (ACETAMINOPHEN CHLOEPHENIRAMINE MALEATE DEXTROMETHORPHAN PHENYLEPHERINE HYDROCHLORIDE CAPSULE LIQUID FILLED) CAPSULE, LIQUID FILLED [TERESA CECENA DBA GENESIS]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DXL3 XTRA (ACETAMINOPHEN CHLOEPHENIRAMINE MALEATE DEXTROMETHORPHAN PHENYLEPHERINE HYDROCHLORIDE CAPSULE LIQUID FILLED) CAPSULE, LIQUID FILLED [TERESA CECENA DBA GENESIS]1
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UXL3 XTRA (ACETAMINOPHEN CHLOEPHENIRAMINE MALEATE DEXTROMETHORPHAN PHENYLEPHERINE HYDROCHLORIDE CAPSULE LIQUID FILLED) CAPSULE, LIQUID FILLED [TERESA CECENA DBA GENESIS]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSXL3 XTRA (ACETAMINOPHEN CHLOEPHENIRAMINE MALEATE DEXTROMETHORPHAN PHENYLEPHERINE HYDROCHLORIDE CAPSULE LIQUID FILLED) CAPSULE, LIQUID FILLED [TERESA CECENA DBA GENESIS]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVXL3 XTRA (ACETAMINOPHEN CHLOEPHENIRAMINE MALEATE DEXTROMETHORPHAN PHENYLEPHERINE HYDROCHLORIDE CAPSULE LIQUID FILLED) CAPSULE, LIQUID FILLED [TERESA CECENA DBA GENESIS]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LXL3 XTRA (ACETAMINOPHEN CHLOEPHENIRAMINE MALEATE DEXTROMETHORPHAN PHENYLEPHERINE HYDROCHLORIDE CAPSULE LIQUID FILLED) CAPSULE, LIQUID FILLED [TERESA CECENA DBA GENESIS]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDXL3 XTRA (ACETAMINOPHEN CHLOEPHENIRAMINE MALEATE DEXTROMETHORPHAN PHENYLEPHERINE HYDROCHLORIDE CAPSULE LIQUID FILLED) CAPSULE, LIQUID FILLED [TERESA CECENA DBA GENESIS]1
GELATININACTIVE INGREDIENT2G86QN327LXL3 XTRA (ACETAMINOPHEN CHLOEPHENIRAMINE MALEATE DEXTROMETHORPHAN PHENYLEPHERINE HYDROCHLORIDE CAPSULE LIQUID FILLED) CAPSULE, LIQUID FILLED [TERESA CECENA DBA GENESIS]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXXL3 XTRA (ACETAMINOPHEN CHLOEPHENIRAMINE MALEATE DEXTROMETHORPHAN PHENYLEPHERINE HYDROCHLORIDE CAPSULE LIQUID FILLED) CAPSULE, LIQUID FILLED [TERESA CECENA DBA GENESIS]1
POLYETHYLENE GLYCOL 1000INACTIVE INGREDIENTU076Q6Q621XL3 XTRA (ACETAMINOPHEN CHLOEPHENIRAMINE MALEATE DEXTROMETHORPHAN PHENYLEPHERINE HYDROCHLORIDE CAPSULE LIQUID FILLED) CAPSULE, LIQUID FILLED [TERESA CECENA DBA GENESIS]1
POLYETHYLENE GLYCOL 600INACTIVE INGREDIENTNL4J9F21N9XL3 XTRA (ACETAMINOPHEN CHLOEPHENIRAMINE MALEATE DEXTROMETHORPHAN PHENYLEPHERINE HYDROCHLORIDE CAPSULE LIQUID FILLED) CAPSULE, LIQUID FILLED [TERESA CECENA DBA GENESIS]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EXL3 XTRA (ACETAMINOPHEN CHLOEPHENIRAMINE MALEATE DEXTROMETHORPHAN PHENYLEPHERINE HYDROCHLORIDE CAPSULE LIQUID FILLED) CAPSULE, LIQUID FILLED [TERESA CECENA DBA GENESIS]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3XL3 XTRA (ACETAMINOPHEN CHLOEPHENIRAMINE MALEATE DEXTROMETHORPHAN PHENYLEPHERINE HYDROCHLORIDE CAPSULE LIQUID FILLED) CAPSULE, LIQUID FILLED [TERESA CECENA DBA GENESIS]1
WATERINACTIVE INGREDIENT059QF0KO0RXL3 XTRA (ACETAMINOPHEN CHLOEPHENIRAMINE MALEATE DEXTROMETHORPHAN PHENYLEPHERINE HYDROCHLORIDE CAPSULE LIQUID FILLED) CAPSULE, LIQUID FILLED [TERESA CECENA DBA GENESIS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69772-440XL3 XTRA (ACETAMINOPHEN CHLOEPHENIRAMINE MALEATE DEXTROMETHORPHAN PHENYLEPHERINE HYDROCHLORIDE CAPSULE LIQUID FILLED) CAPSULE, LIQUID FILLED [TERESA CECENA DBA GENESIS]1Legacy NDC, 2 package rows20150903_1cbb8491-6ef7-45af-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1193292acetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSN1cbb8491-6ef7-45af-e054-00144ff88e881
1193292acetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD1cbb8491-6ef7-45af-e054-00144ff88e881
1193292APAP 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY1cbb8491-6ef7-45af-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
69772-440-016977204400120 mg in 1 BLISTER PACK20 mgHistorical
69772-440-026977204400212 mg in 1 BLISTER PACK12 mgHistorical