Home NDC 67060-106-68 COLD TABS II
Product NDC 67060-106
Requested package NDC 67060-106-68
11-digit product format 670600106
Labeler code 67060
Product ID 67060-106_0636cfda-4705-4772-9eb8-d831a6d3046d
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL
Dosage form TABLET
Route ORAL
Labeler ADVANCED FIRST AID, INC.
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-04-10
Marketing end 0000-00-00
Substance ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325 1/1; 1/1; 1/1
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67060-106-02 COLD TABS II 2 in 1 PACKET TABLET 2 2 67060-106-68 COLD TABS II 100 in 1 CARTON TABLET 100 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D COLD TABS II (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [ADVANCED FIRST AID, INC.] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ COLD TABS II (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [ADVANCED FIRST AID, INC.] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ COLD TABS II (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [ADVANCED FIRST AID, INC.] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D COLD TABS II (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [ADVANCED FIRST AID, INC.] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ COLD TABS II (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [ADVANCED FIRST AID, INC.] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV COLD TABS II (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [ADVANCED FIRST AID, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U COLD TABS II (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [ADVANCED FIRST AID, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA COLD TABS II (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [ADVANCED FIRST AID, INC.] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E COLD TABS II (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [ADVANCED FIRST AID, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A CORN INACTIVE INGREDIENT AG9B65PV6B COLD TABS II (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [ADVANCED FIRST AID, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ COLD TABS II (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [ADVANCED FIRST AID, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP COLD TABS II (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [ADVANCED FIRST AID, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67060-106 COLD TABS II (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [ADVANCED FIRST AID, INC.] 2 Legacy NDC, 2 package rows 20161025_cdbe0b3a-ced3-465c-92a1-a526bbd07f09.zip
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 67060-106-68 67060010668 100 PACKET in 1 CARTON (67060-106-68) > 2 TABLET in 1 PACKET (67060-106-02) 100 packet 2015-04-10 0000-00-00 No No Current