FDA.reportPublic FDA data

Norel AD

Product NDC
52747-475
11-digit product format
527470475
Labeler code
52747
Product ID
52747-475_41619e00-e834-2cf6-e063-6394a90a259d
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, chlorpheniramine maleate, and phenylephrine HCl
Dosage form
TABLET, MULTILAYER
Route
ORAL
Labeler
U.S. PHARMACEUTICAL CORPORATION
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-04-27
Substance
ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 4; 10 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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Norel AD
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
CHLORPHENIRAMINE MALEATE4 mg/1
PHENYLEPHRINE HYDROCHLORIDE10 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
1193293Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
53d9ed3c-212d-4b12-ac35-8bd49382b49dAvailable on FDA.report

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
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
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
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52747-475-70Norel AD20 in 1 BOTTLETABLET, MULTILAYER2014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52747-475-70EA - Each52747-47568275189-3697-4453-b194-5f6a863a3f5b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DNOREL AD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HCL) TABLET, MULTILAYER [US PHARMACEUTICAL CORPORATION]5
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZNOREL AD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HCL) TABLET, MULTILAYER [US PHARMACEUTICAL CORPORATION]5
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJNOREL AD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HCL) TABLET, MULTILAYER [US PHARMACEUTICAL CORPORATION]5
ACETAMINOPHENACTIVE MOIETY362O9ITL9DNOREL AD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HCL) TABLET, MULTILAYER [US PHARMACEUTICAL CORPORATION]5
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UNOREL AD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HCL) TABLET, MULTILAYER [US PHARMACEUTICAL CORPORATION]5
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVNOREL AD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HCL) TABLET, MULTILAYER [US PHARMACEUTICAL CORPORATION]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNOREL AD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HCL) TABLET, MULTILAYER [US PHARMACEUTICAL CORPORATION]5
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NOREL AD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HCL) TABLET, MULTILAYER [US PHARMACEUTICAL CORPORATION]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKNOREL AD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HCL) TABLET, MULTILAYER [US PHARMACEUTICAL CORPORATION]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNOREL AD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HCL) TABLET, MULTILAYER [US PHARMACEUTICAL CORPORATION]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NOREL AD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HCL) TABLET, MULTILAYER [US PHARMACEUTICAL CORPORATION]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NOREL AD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HCL) TABLET, MULTILAYER [US PHARMACEUTICAL CORPORATION]5
POVIDONE K30INACTIVE INGREDIENTU725QWY32XNOREL AD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HCL) TABLET, MULTILAYER [US PHARMACEUTICAL CORPORATION]5
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJNOREL AD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HCL) TABLET, MULTILAYER [US PHARMACEUTICAL CORPORATION]5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APNOREL AD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HCL) TABLET, MULTILAYER [US PHARMACEUTICAL CORPORATION]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52747-475NOREL AD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HCL) TABLET, MULTILAYER [U.S. PHARMACEUTICAL CORPORATION]13Current NDC, Legacy NDC, 1 package rows20241017_53d9ed3c-212d-4b12-ac35-8bd49382b49d.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 151 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cough DropsMENTHOLUnited Natural Foods, Inc.f9f0d020-e031-245e-e053-6294a90addb52024-10-08WarningsExact identifier
application number: M012
Cough DropsMENTHOLUnited Natural Foods, Inc.fb7ee463-8003-a306-e053-6294a90a82592024-10-08WarningsExact identifier
application number: M012
Cough DropsMENTHOLUnited Natural Foods, Inc.fb7e4a84-d2c2-65e5-e053-6394a90a0c722024-10-08WarningsExact identifier
application number: M012
Cough DropsCHERRYUnited Natural Foods, Inc.f9f0e853-6997-a49b-e053-6294a90aa4b82024-10-08WarningsExact identifier
application number: M012
Cough DropsMENTHOLUnited Natural Foods, Inc.fb7fa728-911d-aaf0-e053-6394a90ace312024-10-08WarningsExact identifier
application number: M012
Cough DropsMENTHOLUnited Natural Foods, Inc.fb7f3b84-1e61-eadf-e053-6394a90a9e5c2024-10-08WarningsExact identifier
application number: M012
Cough DropsMENTHOLUnited Natural Foods, Inc.fb7f515f-7302-d153-e053-6394a90a08342024-10-08WarningsExact identifier
application number: M012
Rompe Pecho NT NTACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEEfficient Laboratories Inc06faafaa-50a6-c16e-e063-6294a90a49cb2024-10-08WarningsExact identifier
application number: M012
Mucus Relief Cough and Congestion DMGUAIFENESIN AND DEXTROMETHORPHAN HBRBryant Ranch Prepack8c25285e-e2cd-4e10-af63-5dce8098b6152024-10-08WarningsExact identifier
application number: M012
Severe Throat Sore DropsMENTHOLTarget Corporation Inc.949543d5-5043-ac06-e053-2995a90ab3982024-10-07WarningsExact identifier
application number: M012
Natural Herbal Cough DropsCOUGH DROPSTarget Corporation Inc.a23ddfa9-19e0-99ee-e053-2a95a90a68562024-10-07WarningsExact identifier
application number: M012
Cough DropsSIMPLY MENTHOL COUGH DROPSPerrigo Direct, Inc.fb809c63-94f1-bb7a-e053-6294a90a0a392024-10-07WarningsExact identifier
application number: M012
Cough DropsSIMPLY CHERRY COUGH DROPSPerrigo Direct, Inc.fb808dc5-bf63-836c-e053-6294a90a80aa2024-10-07WarningsExact identifier
application number: M012
Cough DropsSIMPLY HONEY LEMONPerrigo Direct Inc.fb898616-d604-b4c3-e053-6294a90a23bf2024-10-07WarningsExact identifier
application number: M012
Natural Herb Cough DropsMENTHOL HERBCVS Pharmacyfcd16063-abca-49a0-e053-6294a90acb262024-10-07WarningsExact identifier
application number: M012
Lemon Mint Herb Throat DropsSUGAR FREE LEMON MINT HERBCVS Pharmacyfce6b5fa-846d-9911-e053-6294a90afc9b2024-10-07WarningsExact identifier
application number: M012
Sugar Free Cough DropsMENTHOLCVS Pharmacyfcd053e9-92ef-70ba-e053-6294a90aa4dd2024-10-07WarningsExact identifier
application number: M012
Sugar Free Cough DropsHONEY LEMONCVS Pharmacyf074a64d-dc01-1a37-e053-2995a90adc492024-10-07WarningsExact identifier
application number: M012
Cough DropsHONEY LEMONCVS Pharmacyf075010d-a07a-5e9d-e053-2995a90a3ca32024-10-07WarningsExact identifier
application number: M012
Sugar Free Cough DropsHONEY LEMONCVS Pharmacyfcd053e9-92ee-70ba-e053-6294a90aa4dd2024-10-07WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1193293acetaminophen 325 MG / chlorpheniramine maleate 4 MG / phenylephrine HCl 10 MG Oral TabletPSN53d9ed3c-212d-4b12-ac35-8bd49382b49d14
1193293acetaminophen 325 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral TabletSCD53d9ed3c-212d-4b12-ac35-8bd49382b49d14
1193293APAP 325 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral TabletSY53d9ed3c-212d-4b12-ac35-8bd49382b49d14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52747-475-705274704757020 TABLET, MULTILAYER in 1 BOTTLE (52747-475-70) 2012-04-270000-00-00NoNoCurrent