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 9 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aspirin Low Dose ASPIRIN ARMY AND AIR FORCE EXCHANGE SERVICE e273ead7-7cbc-4fd5-a136-9d3558a35360 2026-06-24 Warnings Exact identifier application number: M013 Acetaminophen Regular Strength ACETAMINOPHEN CVS PHARMACY 5e35df92-6282-4ca6-902b-bb6bd326b487 2026-06-23 Warnings Exact identifier application number: M013 Pain Reliever ACETAMINOPHEN Orelli Inc. 4f9f1b4e-8bbb-49b9-8e6c-263edb2c084d 2026-06-22 Warnings Exact identifier application number: M013 Pain Relief Aspirin Chewable, Low Dose ASPIRIN Rite Aid Corporation 65cdce0f-be04-43ba-8c68-bdce7983cfa1 2026-06-22 Warnings Exact identifier application number: M013 Aspirin Regimen ASPIRIN Cardinal Health 110, LLC. DBA Leader 88f425df-712d-4911-824b-94085c7190b6 2026-06-19 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN Meijer Distribution, Inc. 3716a7d4-a555-4e54-aa0a-7b8f3e32addb 2026-06-19 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN DOLGENCORP, LLC acc94a3e-21b6-4375-9881-38cf9bab8692 2026-06-19 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN L.N.K. International, Inc. 2f6ec676-3832-420e-be91-fce83f6586c8 2026-06-19 Warnings Exact identifier application number: M013 Headache Relief ACETAMINOPHEN, ASPIRIN, CAFFEINE DOLGENCORP, LLC e1e24d52-0b4d-400b-8181-e3f6ab75c4f6 2026-06-18 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Oncor Pharmaceuticals 4c396d0e-aa93-4f9e-b065-2e606f7f05cd 2026-06-17 Warnings Exact identifier application number: M013 LOW DOSE ASPIRIN ASPIRIN Famora Inc. 4dc6f119-bbde-db5f-e063-6294a90a9486 2026-06-16 Warnings Exact identifier application number: M013 Childrens Pain and Fever Relief ACETAMINOPHEN Chain Drug Marketing Association, Inc. 420a1e05-caa6-481f-bdab-a670f0220f96 2026-06-16 Warnings Exact identifier application number: M013 Pain Relief Extra Strength ACETAMINOPHEN DOLGENCORP, LLC ce9f4e0d-43fb-499a-b8a2-a997a14841c4 2026-06-16 Warnings Exact identifier application number: M013 Pain Reliever ACETAMINOPHEN L.N.K. International, Inc. 734cc3d2-6fc5-4dcc-93ed-0b57c1f01345 2026-06-15 Warnings Exact identifier application number: M013 RIGHT REMEDIES EXTRA STRENGTH Pain Relief PM Caplet ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE Strive Pharmaceuticals Inc. 2d63671d-cf7c-bbdd-e063-6294a90affef 2026-06-15 Warnings Exact identifier application number: M013 TYLENOL Extra Strength ACETAMINOPHEN Kenvue Brands LLC 59773893-09a8-47a2-943a-e9ea9da4458a 2026-06-15 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN Shield Pharmaceuticals Corp. 96eb7f9f-ff2d-4661-bbe6-1860aafe03f6 2026-06-15 Warnings Exact identifier application number: M013 Duralgina Extra Strength ACETAMINOPHEN Menper Distributors, Inc. 544e3d7e-a759-384f-e063-6294a90a5baa 2026-06-15 Warnings Exact identifier application number: M013 pain relief childrens ACETAMINOPHEN Rite Aid Corporation be2286a1-946b-4bf5-b14c-8e86da669594 2026-06-15 Warnings Exact identifier application number: M013 Aspirin 81 ASPIRIN Amerisource Bergen 4491faca-f30b-4eb0-bea9-f518f6b2f095 2026-06-15 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