FDA.reportPublic FDA data

DayTime Sinus

Product NDC
53345-030
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 62 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar Services Incb9215a5e-3be8-44fd-9189-50dab760869c2026-01-06WarningsExact identifier
application number: M012
Night Time Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMajor Pharmaceuticalsf81efbf4-204b-45be-ae32-910d9e4ae4aa2026-01-06WarningsExact identifier
application number: M012
SINUS AND NASAL DECONGESTANTPSEUDOEPHEDRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd7646859-f996-46cd-a0b9-56b860f609012026-01-05WarningsExact identifier
application number: M012
HyVee Cough Drops Honey LemonMENTHOLHY-VEE, INC47a71cdf-856d-9ecd-e063-6294a90a70c62026-01-05WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINOncor Pharmaceuticalsfd35036c-b722-48a3-85fd-60471beb6e742026-01-05WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HCLNuCare Pharmaceuticals,Inc.3c323dc8-f734-b44c-e063-6394a90a61842026-01-05WarningsExact identifier
application number: M012
Congestion and Cough ChildrensDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACYf43d97b1-aeb9-4ca5-8909-b28e7bf764f52026-01-05WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWinCo Foods, LLC6bd2b8fd-2023-413b-8988-a47d2058dc852026-01-05WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWinCo Foods, LLC4c1046df-53a6-4219-83ac-bbf5cf4db9c82026-01-05WarningsExact identifier
application number: M012
Night Time Cold and Flu Relief Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEP & L Development, LLC80323208-9ba5-432b-a8a0-0c0b51e671452026-01-05WarningsExact identifier
application number: M012
Sinus Pressure and Pain PE Maximum StrengthACETAMINOPHEN AND PHENYLEPHRINE HCLRite Aid Corporation347868e4-0182-4e16-895c-ec269895c57c2026-01-02WarningsExact identifier
application number: M012
HyVee Cough Drops CherryMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.c5b11a9c-6d93-4772-93c2-1ef5c56470162026-01-02WarningsExact identifier
application number: M012
HyVee Cough Drops Honey LemonMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.fae96736-1453-42fe-8158-cde770b231652026-01-02WarningsExact identifier
application number: M012
HyVee Cough Drops MentholMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.8cac1229-8e8e-4d8c-9f18-c2cd0f6f50bd2026-01-02WarningsExact identifier
application number: M012
Reliable-1 TussinGUAIFENESINRELIABLE 1 LABORATORIES LLC2a33ff82-49df-7aaa-e063-6294a90a12812026-01-02WarningsExact identifier
application number: M012
Tussin DMMaxDEXTROMETHORPHAN HBR, GUAIFENESINRELIABLE 1 LABORATORIES LLCc4bb2e12-e0f6-4cbf-ad24-cfad9326f7fa2026-01-02WarningsExact identifier
application number: M012
Severe Sinus Pain and Congestion DaytimeACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLCVS Pharmacy4af347ce-9745-4a5e-8ce9-e7c97a0a6cc72026-01-02WarningsExact identifier
application number: M012
NUVALU VAPORIZING CHEST RUBCAMPHOR, EUCALYPTUS OIL, MENTHOLJC SALES490b2d1e-3a1d-1a52-e063-6394a90a00ba2026-01-01WarningsExact identifier
application number: M012
NUVALU VAPORIZING CHEST RUBCAMPHOR, EUCALYPTUS OIL, MENTHOLNingbo Liyuan Daily Chemical Products Co., Ltd.4947540b-73c9-d44a-e063-6294a90a9d372026-01-01WarningsExact identifier
application number: M012
PANCOLD AACETAMINOPHEN, GUAIFENESIN, PENTOXYVERINE CITRATE, PHENYLPEHRINE HYDCROCHLORIDE, CHLORPHENIRAMINE MALEATE, CAFFEINE ANHYDROUSDONGWHA PHARM. CO. LTD.fc8f1807-d344-ccc2-e053-6294a90a50892025-12-31WarningsExact 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