EXTRA FAST COLTALIN

Product NDC
51467-014
11-digit product format
514670014
Labeler code
51467
Product ID
51467-014_4abea51d-b316-7c9c-e063-6294a90a7046
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Chlorpheniramine maleate, Phenylephrine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
FORTUNE PHARMACAL COMPANY LIMITED
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-30
Substance
ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 2; 5 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
EXTRA FAST COLTALIN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
CHLORPHENIRAMINE MALEATE2 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, V1Q0O9OJ9Z, 04JA59TNSJ
Rxcui1046781

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
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3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
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22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
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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
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
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e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51467-014-01EXTRA FAST COLTALIN2 in 1 BOXTABLET23
51467-014-01EXTRA FAST COLTALIN12 in 1 BLISTER PACKTABLET123
51467-014-02EXTRA FAST COLTALIN12 in 1 BLISTER PACKTABLET123
51467-014-02EXTRA FAST COLTALIN3 in 1 BOXTABLET33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51467-014EXTRA FAST COLTALIN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET [FORTUNE PHARMACAL COMPANY LIMITED]1Current NDC, 4 package rows20241228_1a28fea6-095f-4488-92aa-e6bd8908e17b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046781acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine HCl 5 MG Oral TabletPSN1a28fea6-095f-4488-92aa-e6bd8908e17b3
1046781acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD1a28fea6-095f-4488-92aa-e6bd8908e17b3
1046781APAP 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral TabletSY1a28fea6-095f-4488-92aa-e6bd8908e17b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51467-014-01514670014012 BLISTER PACK in 1 BOX (51467-014-01) / 12 TABLET in 1 BLISTER PACK2 blister pack2026-01-30NoNoCurrent
51467-014-02514670014023 BLISTER PACK in 1 BOX (51467-014-02) / 12 TABLET in 1 BLISTER PACK3 blister pack2026-01-30NoNoCurrent