CHILDRENS COLTALIN

Product NDC
51467-006
11-digit product format
514670006
Labeler code
51467
Product ID
51467-006_438114b4-2333-cb26-e063-6294a90a5984
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
FORTUNE PHARMACAL COMPANY LIMITED
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2004-03-01
Substance
ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
80; .5; 1.25 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CHILDRENS COLTALIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN80 mg/1
CHLORPHENIRAMINE MALEATE.5 mg/1
PHENYLEPHRINE HYDROCHLORIDE1.25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
V1Q0O9OJ9ZInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1540507Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98748cbc-b567-4ef9-b7f7-fe74645935d4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51467-006-01CHILDRENS COLTALIN24 in 1 CARTONTABLET, CHEWABLE246

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DCHILDRENS COLTALIN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, CHEWABLE [FORTUNE PHARMACAL COMPANY LIMITED]1
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZCHILDRENS COLTALIN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, CHEWABLE [FORTUNE PHARMACAL COMPANY LIMITED]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJCHILDRENS COLTALIN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, CHEWABLE [FORTUNE PHARMACAL COMPANY LIMITED]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DCHILDRENS COLTALIN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, CHEWABLE [FORTUNE PHARMACAL COMPANY LIMITED]1
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UCHILDRENS COLTALIN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, CHEWABLE [FORTUNE PHARMACAL COMPANY LIMITED]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVCHILDRENS COLTALIN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, CHEWABLE [FORTUNE PHARMACAL COMPANY LIMITED]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1CHILDRENS COLTALIN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, CHEWABLE [FORTUNE PHARMACAL COMPANY LIMITED]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCHILDRENS COLTALIN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, CHEWABLE [FORTUNE PHARMACAL COMPANY LIMITED]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CHILDRENS COLTALIN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, CHEWABLE [FORTUNE PHARMACAL COMPANY LIMITED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CHILDRENS COLTALIN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, CHEWABLE [FORTUNE PHARMACAL COMPANY LIMITED]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ACHILDRENS COLTALIN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, CHEWABLE [FORTUNE PHARMACAL COMPANY LIMITED]1
PINEAPPLEINACTIVE INGREDIENT2A88ZO081OCHILDRENS COLTALIN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, CHEWABLE [FORTUNE PHARMACAL COMPANY LIMITED]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XCHILDRENS COLTALIN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, CHEWABLE [FORTUNE PHARMACAL COMPANY LIMITED]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCHILDRENS COLTALIN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, CHEWABLE [FORTUNE PHARMACAL COMPANY LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51467-006CHILDRENS COLTALIN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, CHEWABLE [FORTUNE PHARMACAL COMPANY LIMITED]5Current NDC, Legacy NDC, 1 package rows20241121_98748cbc-b567-4ef9-b7f7-fe74645935d4.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 194 · 3,880 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar Services Incce590997-3cae-4f22-ac39-2b14d39494bc2026-07-30WarningsExact identifier
application number: M012
Robitussin Direct CoughDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC70c9556b-063a-4fb3-96f6-1d4ffa495ed42026-07-30WarningsExact identifier
application number: M012
Major Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.a302e341-1c00-4c3d-b71f-c4c0b307aa672026-07-29WarningsExact identifier
application number: M012
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreens4c737cd6-fe56-4cef-887c-cd6cf83b254c2026-07-29WarningsExact identifier
application number: M012
ROBITUSSIN LONG-ACTING COUGHGELSDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC472c5c1f-eb5a-444b-a17e-f0d71007fb152026-07-29WarningsExact identifier
application number: M012
DAYTIME COLD AND FLU NITETIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEMeijer Distribution Inc3a33c6ce-aada-4099-8c61-49c86c0fc1a82026-07-29WarningsExact identifier
application number: M012
Tussin DM Max NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWal-Mart Stores Inc668c92ce-6c1f-4ab3-b0dd-822b0768cb5e2026-07-29WarningsExact identifier
application number: M012
BenadrylDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC702f9786-7ce9-43e4-921d-e1db096121272026-07-28WarningsExact identifier
application number: M012
LoHist-DCHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCLLarken Laboratories, Inc.efaa354e-c25c-405b-9d30-001c2796978c2026-07-28WarningsExact identifier
application number: M012
NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd1115a55-35cd-4f20-8872-f42983a5ebcd2026-07-28WarningsExact identifier
application number: M012
TUSSINDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINSafewaya5e2bda4-2da6-4c20-855d-2888dadf0c3a2026-07-28WarningsExact identifier
application number: M012
DM MaximumDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDf6029b04-e681-40fc-be4f-14091b76dd4e2026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLCVS PHARMACYe958eef1-8aae-4365-ac64-95a9e8e7e0f22026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLDOLGENCORP INC38400854-27fa-e291-e063-6294a90a5c4e2026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLBetter Living Brands, LLC65802aa7-64e7-4435-ad6b-65895fba17ce2026-07-27WarningsExact identifier
application number: M012
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCLWalgreen Company0a48f650-ad2a-4105-9ff4-2bc4d94b46d32026-07-27WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company84202ebe-97b6-4be2-bb09-7f2729303f962026-07-27WarningsExact identifier
application number: M012
Daytime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation8d41defe-8120-4cbb-b42e-c805cc5a794b2026-07-24WarningsExact identifier
application number: M012
Childrens Benadryl ALLERGYDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLCfc9181b9-c92d-493e-8d7c-4a4239c6c0922026-07-24WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDEProdose, Inc.3afc88c7-388a-dbd9-e063-6294a90a4faf2026-07-24WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1540507acetaminophen 80 MG / chlorpheniramine maleate 0.5 MG / phenylephrine HCl 1.25 MG Chewable TabletPSN98748cbc-b567-4ef9-b7f7-fe74645935d46
1540507acetaminophen 80 MG / chlorpheniramine maleate 0.5 MG / phenylephrine hydrochloride 1.25 MG Chewable TabletSCD98748cbc-b567-4ef9-b7f7-fe74645935d46
1540507APAP 80 MG / Chlorpheniramine Maleate 0.5 MG / Phenylephrine Hydrochloride 1.25 MG Chewable TabletSY98748cbc-b567-4ef9-b7f7-fe74645935d46

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51467-006-015146700060124 TABLET, CHEWABLE in 1 CARTON (51467-006-01) 2004-03-010000-00-00NoNoCurrent