Home NDC 42961-112 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 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 date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 42961-112 42961-112-12 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 42961-112 42961-112-11 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…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 Ingredient Strength GUAIFENESIN 200 mg/1 ACETAMINOPHEN 325 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 495W7451VQ Internal UNII lookup 362O9ITL9D Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1243679 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42961-112-10 Xpect Cold Relief 2 in 1 PACKET TABLET 2 10 42961-112-11 Xpect Cold Relief 80 in 1 BOX TABLET 80 10 42961-112-12 Xpect Cold Relief 200 in 1 BOX TABLET 200 10 42961-112-13 Xpect Cold Relief 25 in 1 BAG TABLET 25 10 42961-112-14 Xpect Cold Relief 40 in 1 BOX TABLET 40 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42961-112 XPECT COLD RELIEF (ACETAMINOPHEN GUAIFENESEIN PHENYLEPHRINE HCL) TABLET [CINTAS CORPORATION] 8 Current NDC, Legacy NDC, 5 package rows 20241226_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 46 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join RIGHT REMEDIES LOW DOSE Aspirin 81mg ASPIRIN Strive Pharmaceuticals Inc. 322c0e50-cf75-51ab-e063-6294a90a9235 2025-04-14 Warnings Exact identifier application number: M013 Bayer Aspirin Regimen Chewable Low Dose Aspirin Orange ASPIRIN Bayer HealthCare LLC. 0c6ae05f-760f-34d1-e054-00144ff88e88 2025-04-11 Warnings Exact identifier application number: M013 Arthriten Inflammatory Pain Formula ACETAMINOPHEN, ASPIRIN, CAFFEINE Kobayashi Healthcare International, Inc c280ca89-4fb5-4050-90ee-d706a550a1ef 2025-04-11 Warnings Exact identifier application number: M013 Bayer Back and Body Extra Strength ASPIRIN,CAFFEINE Bayer HealthCare LLC. 0c77c484-6caf-12ca-e054-00144ff88e88 2025-04-10 Warnings Exact identifier application number: M013 Adult Low Dose Enteric Coated Aspirin ASPIRIN NuCare Pharmaceuticals, Inc. 324937c3-c558-bc79-e063-6294a90acc8e 2025-04-08 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN 500MG CVS Pharmacy, Inc. 1fde6487-6682-99a3-e063-6294a90a3670 2025-04-04 Warnings Exact identifier application number: M013 Childrens Acetaminophen ACETAMINOPHEN Bryant Ranch Prepack bdc466c9-d9ae-4293-b7ea-46fb517661c6 2025-04-01 Warnings Exact identifier application number: M013 Adult Low Dose Enteric Coated Aspirin ASPIRIN Geri-Care Pharmaceutical Corp e327a52a-0e31-44b7-9823-7f60d070ae52 2025-04-01 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Proficient Rx LP 9af5ccc8-aac0-4339-a9f6-58fdc9b91c57 2025-04-01 Warnings Exact identifier application number: M013 ASPIRIN 325 MG EC ASPIRIN Bryant Ranch Prepack 9d0449d2-c0c6-4e74-931b-35dc62584028 2025-03-31 Warnings Exact identifier application number: M013 Aspirin 81 mg ASPIRIN Bryant Ranch Prepack cce1e8bd-63c8-403a-bc32-e6788493f604 2025-03-31 Warnings Exact identifier application number: M013 Adwe Feverx Acetaminophen Caplets, 500 mg Extra Strength ACETAMINOPHEN Aurex Laboratories Limited Liability Company 948c5826-6f35-484d-bb3f-cecf6a4b5c13 2025-03-31 Warnings Exact identifier application number: M013 Infants Pain and Fever ACETAMINOPHEN WALGREENS 281a530b-c759-50eb-e063-6394a90abb4f 2025-03-28 Warnings Exact identifier application number: M013 Pain Reliever PM ACETAMINOPHEN, DIPHENHYDRAMINE HCL WR Group, Inc. 8281771c-485c-42a9-9a1c-9a7a4298c5b8 2025-03-28 Warnings Exact identifier application number: M013 Acetaminophen Regular strength ACETAMINOPHEN PD-Rx Pharmaceuticals, Inc. 4181efc2-d183-410c-b647-233444c57e32 2025-03-20 Warnings Exact identifier application number: M013 CounterAct Pain ACETAMINOPHEN Melaleuca, Inc. 7faf76b4-7f25-377d-e053-2a91aa0a19d4 2025-03-20 Boxed warning, Warnings Exact identifier application number: M013 Mejoral ACETAMINOPHEN, CAFFEINE OPMX LLC 0bccf571-fcb9-2dd5-e063-6294a90a5f16 2025-03-19 Warnings Exact identifier application number: M013 ARTRIFIN 24 CAPLETS ACETAMINOPHEN, ASPIRIN, CAFFEINE OPMX LLC e7f15c2b-a730-b54f-e053-2a95a90a3b3e 2025-03-19 Warnings Exact identifier application number: M013 Pain Reliever PM ACETAMINOPHEN, DIPHENHYDRAMINE HCL TARGET Corporation 1fc3806e-a5c4-4a6e-951b-dfbf9f5771f1 2025-03-17 Warnings Exact identifier application number: M013 Signature Select Effervescent Pain Relief ASPIRIN Safeway Inc. 304fca65-2867-c963-e063-6394a90a183f 2025-03-14 Warnings Exact identifier application number: M013
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42961-112-03 42961011203 80 PACKET in 1 BOX (42961-112-03) > 2 TABLET in 1 PACKET (42961-112-01) 80 packet 2021-03-29 0000-00-00 No No Current 42961-112-10 42961011210 2 in 1 PACKET Historical 42961-112-11 42961011211 80 PACKET in 1 BOX (42961-112-11) > 2 TABLET in 1 PACKET (42961-112-10) 80 packet 2021-03-29 0000-00-00 No No Current 42961-112-12 42961011212 200 PACKET in 1 BOX (42961-112-12) > 2 TABLET in 1 PACKET (42961-112-10) 200 packet 2022-12-30 0000-00-00 No No Current 42961-112-13 42961011213 25 PACKET in 1 BAG (42961-112-13) / 2 TABLET in 1 PACKET (42961-112-10) 25 packet 2025-09-23 No No Current 42961-112-14 42961011214 40 PACKET in 1 BOX (42961-112-14) / 2 TABLET in 1 PACKET (42961-112-10) 40 packet 2025-09-23 No No Current