FDA.reportPublic FDA data

Xpect Cold Relief

Product NDC
42961-112
11-digit product format
429610112
Labeler code
42961
Product ID
42961-112_59bbb82a-0247-417c-b0ed-991646373be8
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen Guaifenesein Phenylephrine HCl
Dosage form
TABLET
Route
ORAL
Labeler
Cintas Corporation
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-29
Substance
GUAIFENESIN; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
200; 325; 5 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage42961-11242961-112-11DDiscontinued by firm2026-10-16
excluded packagepackage42961-11242961-112-12DDiscontinued by firm2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42961-11242961-112-12DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42961-11242961-112-11DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
Xpect Cold Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN200 mg/1
ACETAMINOPHEN325 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
495W7451VQInternal UNII lookup
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
1243679Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
02391d55-32b2-4083-9315-98e9b3650c55Available 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
377068df-225f-7318-a910-a1987cdfa361Product name320170608
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
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
42961-112-10Xpect Cold Relief2 in 1 PACKETTABLET210
42961-112-11Xpect Cold Relief80 in 1 BOXTABLET8010
42961-112-12Xpect Cold Relief200 in 1 BOXTABLET20010
42961-112-13Xpect Cold Relief25 in 1 BAGTABLET2510
42961-112-14Xpect Cold Relief40 in 1 BOXTABLET4010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42961-112XPECT COLD RELIEF (ACETAMINOPHEN GUAIFENESEIN PHENYLEPHRINE HCL) TABLET [CINTAS CORPORATION]8Current NDC, Legacy NDC, 5 package rows20241226_02391d55-32b2-4083-9315-98e9b3650c55.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 51 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pediacare Childrens Acetaminophen GrapeACETAMINOPHENRANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH596372c7-eca3-4527-8e22-ab0751e2526b2024-12-30WarningsExact identifier
application number: M013
Bayer Genuine AspirinBAYER GENUINE ASPIRINLil' Drug Store Products, Inc.d17834d7-cb3e-6bf2-e053-2a95a90ae5c12024-12-30WarningsExact identifier
application number: M013
Extra Strength Pain RelieverACETAMINOPHEN 500 MG, FILM-COATED CAPLETLil' Drug Store Products, Inc.e5fd2b46-683e-4cf5-e053-2995a90a55122024-12-30WarningsExact identifier
application number: M013
Night Time Severe Cold and Cough ReliefACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLChain Drug Consortium, LLCc8e9b57b-83e9-46c5-9791-02c4c2b940042024-12-29WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION INC.1608b4f0-bf20-4024-b8f2-20a4df7a4b212024-12-26WarningsExact identifier
application number: M013
AspirinASPIRINAdvance Pharmaceutical Inc.f6a9ea44-08b8-4a33-bfbd-68cb2d852c392024-12-26WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION INCcfc7eac3-35be-4002-b8ef-be1dfc8caf692024-12-26WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION INCa3031139-4709-43f2-95a8-89840c595f7f2024-12-26WarningsExact identifier
application number: M013
Acetaminophen 250mg Aspirin 250mg Caffeine 65mgACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MGWALGREENS CO.98bb28ed-d146-ca3d-e053-2a95a90a9eaf2024-12-26WarningsExact identifier
application number: M013
Acetaminophen 500mg Caffeine 60mg Pyrilamine maleate 15mgACETAMINOPHEN 500MG CAFFEINE 60MG PYRILAMINE MALEATE 15MGWALGREENS CO.982faa74-d498-cd1e-e053-2995a90afa1e2024-12-25WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAptaPharma Inc.11bf6e1b-aed9-4f8f-9f03-ea911ae9f7022024-12-23WarningsExact identifier
application number: M013
Rugby Regular Strength AcetaminophenACETAMINOPHENRUGBY LABORATORIES295b0d00-4d4a-405f-9325-d01c5d4f3ed42024-12-20WarningsExact identifier
application number: M013
Walgreens Pain Relief PowderASPIRIN AND CAFFEINEWalgreens Co.61493d34-2432-4683-9b32-e1851a4337be2024-12-18WarningsExact identifier
application number: M013
Reese Headache PowdersASPIRIN AND CAFFEINEReese Pharmaceutical Co386f7a6c-4bfc-4140-a67b-07f6b520d58f2024-12-18WarningsExact identifier
application number: M013
NobleAid PAIN RELIEVERASPIRINNoble Otc LLCaa08e488-2f69-4d7e-86ba-ccfad563edcf2024-12-18WarningsExact identifier
application number: M013
Dollar General Headache PowdersASPIRIN AND CAFFEINEDolgencorp, LLC11b0271b-d65c-49c4-a081-d71044a0e04c2024-12-18WarningsExact identifier
application number: M013
Family Wellness Pain Relief PowderASPIRIN AND CAFFEINEFamily Dollar Services Incb2e55de7-3c36-49cc-8f7f-1013fd1ec3592024-12-18WarningsExact identifier
application number: M013
Best Choice Pain Relief PowderASPIRIN AND CAFFEINEValue Mercha95b9b22-ea5c-4a02-b35d-c8ae1e1176042024-12-18WarningsExact identifier
application number: M013
Walmart Pain Relief PowderASPIRIN AND CAFFEINEWalmartc69aa61f-6a74-40a3-8737-195fa545e2612024-12-18WarningsExact identifier
application number: M013
Quality Choice Pain Relief PowderASPIRIN AND CAFFEINEChain Drug Marketing Association8e1f4057-4968-4523-9b3f-55aea421b6742024-12-18WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1243679acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN02391d55-32b2-4083-9315-98e9b3650c5510
1243679acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD02391d55-32b2-4083-9315-98e9b3650c5510
1243679APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY02391d55-32b2-4083-9315-98e9b3650c5510
1243679APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY02391d55-32b2-4083-9315-98e9b3650c5510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42961-112-034296101120380 PACKET in 1 BOX (42961-112-03) > 2 TABLET in 1 PACKET (42961-112-01) 80 packet2021-03-290000-00-00NoNoCurrent
42961-112-10429610112102 in 1 PACKETHistorical
42961-112-114296101121180 PACKET in 1 BOX (42961-112-11) > 2 TABLET in 1 PACKET (42961-112-10) 80 packet2021-03-290000-00-00NoNoCurrent
42961-112-1242961011212200 PACKET in 1 BOX (42961-112-12) > 2 TABLET in 1 PACKET (42961-112-10) 200 packet2022-12-300000-00-00NoNoCurrent
42961-112-134296101121325 PACKET in 1 BAG (42961-112-13) / 2 TABLET in 1 PACKET (42961-112-10) 25 packet2025-09-23NoNoCurrent
42961-112-144296101121440 PACKET in 1 BOX (42961-112-14) / 2 TABLET in 1 PACKET (42961-112-10) 40 packet2025-09-23NoNoCurrent