FDA.reportPublic FDA data

DayTime Sinus

Product NDC
53345-030
Requested package NDC
53345-030-01
11-digit product format
533450030
Labeler code
53345
Product ID
53345-030_27c7af29-b2fe-6a3f-e063-6394a90a9767
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, phenylephrine hydrochloride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-02-26
Substance
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 5 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], 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
DayTime Sinus
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal 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
1052670Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a0b01aef-4248-4d41-862c-0c8884dfca5eAvailable 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
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53345-030-01DayTime Sinus1 in 1 BOXCAPSULE, LIQUID FILLED13
53345-030-01DayTime Sinus4000 in 1 BAGCAPSULE, LIQUID FILLED40003

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DDAYTIME SINUS (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJDAYTIME SINUS (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DDAYTIME SINUS (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVDAYTIME SINUS (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DAYTIME SINUS (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]1
GELATININACTIVE INGREDIENT2G86QN327LDAYTIME SINUS (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDAYTIME SINUS (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADAYTIME SINUS (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EDAYTIME SINUS (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DAYTIME SINUS (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]1
SORBITOLINACTIVE INGREDIENT506T60A25RDAYTIME SINUS (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]1
WATERINACTIVE INGREDIENT059QF0KO0RDAYTIME SINUS (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53345-030DAYTIME SINUS (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]3Current NDC, Legacy NDC, 2 package rows20241127_a0b01aef-4248-4d41-862c-0c8884dfca5e.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 108 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDEMajor Pharmaceuticals1b591e27-b00b-41c8-9fe9-c633aba091342025-08-01WarningsExact identifier
application number: M012
meijer Nighttime Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMeijer, Inc.377248b6-d64d-8dff-e063-6394a90a43f62025-07-31WarningsExact identifier
application number: M012
meijer Daytime Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEMeijer, Inc.3771f778-7ac9-7108-e063-6394a90a11052025-07-31WarningsExact identifier
application number: M012
tussin dmDEXTROMETHORPHAN HBR, GUAIFENESINCVS Pharmacy087d7774-9b0f-44f6-bc1b-4dfbd2f2f6ca2025-07-31WarningsExact identifier
application number: M012
Equate NasalOXYMETAZOLINE HCLWal-Mart Stores Incc38a2783-aed9-466d-8976-59d03a792c042025-07-30WarningsExact identifier
application number: M012
Quality Choice Throat Soothing Drops Creamy StrawberryPECTINXiamen Kang Zhongyuan Biotechnology Co., Ltd.3b15d2ea-f784-275d-e063-6394a90a800c2025-07-29WarningsExact identifier
application number: M012
Respiratory ReliefGUAIFENESINSchwabe North America, Incf683041a-4ff9-42a5-9047-a9a3140a87582025-07-29WarningsExact identifier
application number: M012
Childrens Robitussin Honey Cough and Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINHaleon US Holdings LLCb87f700e-3414-463c-80d4-c3dbca89a4882025-07-29WarningsExact identifier
application number: M012
Tussin DMTUSSIN DMAllegiant Health7a2f8d48-3123-4c37-b238-bd7cc4242bb72025-07-23WarningsExact identifier
application number: M012
Dr. SANA COUGH AND CHEST CONGESTION DM SUGAR FREEDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINGADAL Laboratories, Inc5fb2438b-8f2d-4af2-9981-42d278d268002025-07-23WarningsExact identifier
application number: M012
DR. SANA COUGH AND CHEST CONGESTION DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINGADAL Laboratories, Incbaca0580-4c30-4b94-89fa-a7cf06d4ff252025-07-22WarningsExact identifier
application number: M012
Defensol DACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCIMenper Distributors, Inc.f466c660-69eb-4581-81ff-1499fa421d8b2025-07-22WarningsExact identifier
application number: M012
Defensol D Blister PackACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCIMenper Distributors, Inc.0dfcc977-6101-4536-e063-6294a90a7a482025-07-22WarningsExact identifier
application number: M012
BroncofinDEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLMenper Distributors, Inc.fdf67382-1692-485b-92f1-2cbb8be4fb702025-07-22WarningsExact identifier
application number: M012
Defensol Adult SyrupGUAIFENESIN, DEXTROMETHORPHAN HBRMenper Distributors, Inc.62acff69-8c40-4a0e-8d56-be2cc14e3d452025-07-22WarningsExact identifier
application number: M012
Cosedal DropsDEXTROMETHORPHAN HBR, GUAIFENESINMenper Distributors, Inc.1241d249-ea3b-4d2b-87ed-835d6a2d286a2025-07-22WarningsExact identifier
application number: M012
Berro y Cebolla DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINMenper Distributors, Inc.20107bd9-6d84-4ab5-a0d9-966f1f11d9192025-07-22WarningsExact identifier
application number: M012
Defensol-itoDEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINEMenper Distributors, Inca7c7a60d-d49f-4239-92f7-714eac7eb0c52025-07-22WarningsExact identifier
application number: M012
Bisolvine ChildrenGUAIFENESIN, DEXTROMETHORPHANMENPER DISTRIBUTORS INC.896a5443-e3d2-4af7-9e27-f1c1899ce0382025-07-22WarningsExact identifier
application number: M012
Bisolvine Aloe-MielDEXTROMETHORPHAN, GUAIFENESINMENPER DISTRIBUTORS INC.34801c79-ce88-492f-808e-b639e86016072025-07-22WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1052670acetaminophen 325 MG / phenylephrine HCl 5 MG Oral CapsulePSNa0b01aef-4248-4d41-862c-0c8884dfca5e3
1052670acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDa0b01aef-4248-4d41-862c-0c8884dfca5e3
1052670APAP 325 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSYa0b01aef-4248-4d41-862c-0c8884dfca5e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53345-030-01533450030011 BAG in 1 BOX (53345-030-01) / 4000 CAPSULE, LIQUID FILLED in 1 BAG1 bag2015-02-260000-00-00NoNoCurrent