Home NDC 76168-021 Pain Reliever Fever Reducer
Product NDC 76168-021
11-digit product format 761680021
Labeler code 76168
Product ID 76168-021_240453b0-189a-401e-9f2e-2bf977f7aaa6
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen,Dextromethorphan hydrobromide,Phenylephrine Hydrochloride,Chlorpheniramine Maleate
Dosage form TABLET, EFFERVESCENT
Route ORAL
Labeler Velocity Pharma
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2014-08-15
Marketing end 0000-00-00
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE
Active strength 250 mg/1; mg/1; mg/1; mg/1
NDC exclude flag No
Listing certified through 2019-12-31
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 · 42 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 76168-021-13 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 76168-021-13 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 76168-021-13 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 76168-021-13 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 76168-021-13 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 76168-021-13 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 76168-021-13 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 76168-021-13 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 76168-021-13 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 76168-021-13 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 76168-021-13 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 76168-021-13 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 76168-021-13 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 76168-021-13 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 76168-021-13 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 76168-021-13 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 76168-021-13 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 76168-021-13 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 76168-021-13 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 76168-021-13 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 76168-021-13 9bebd1f3094a…5416666fcb17…
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 76168-021-13 Pain Reliever Fever Reducer 6 in 1 BLISTER PACK TABLET, EFFERVESCENT 6 1 76168-021-13 Pain Reliever Fever Reducer 1 in 1 CARTON TABLET, EFFERVESCENT 1 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D PAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA] 1 CHLORPHENIRAMINE MALEATE ACTIVE INGREDIENT V1Q0O9OJ9Z PAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH PAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ PAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D PAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA] 1 CHLORPHENIRAMINE ACTIVE MOIETY 3U6IO1965U PAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS PAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV PAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA] 1 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 PAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL PAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA] 1 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 PAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA] 1 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O PAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA] 1 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 PAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A PAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA] 1 ORANGE INACTIVE INGREDIENT 5EVU04N5QU PAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H PAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA] 1 PONCEAU 4R INACTIVE INGREDIENT Z525CBK9PG PAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA] 1 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X PAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY PAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU PAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA] 1 SODIUM BICARBONATE INACTIVE INGREDIENT 8MDF5V39QO PAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76168-021 PAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA] 1 Legacy NDC, 2 package rows 20140825_8600db56-a877-4557-ab71-d46b72d642c9.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 76168-021-13 76168002113 6 in 1 BLISTER PACK Historical