Home NDC 62558-001 Doctor Manzanilla Cough Suppressant and Nasal Decongestant
Product NDC 62558-001
11-digit product format 625580001
Labeler code 62558
Product ID 62558-001_1d2c493b-6cb6-4540-9ea2-3a4a909da71e
Type HUMAN OTC DRUG
Nonproprietary name DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
Dosage form SOLUTION
Route ORAL
Labeler Mid Valley Pharmaceuticals LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2014-03-04
Marketing end 0000-00-00
Substance DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 13 mg/5mL; mg/5mL
NDC exclude flag E
Listing certified through 2017-12-31
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 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 62558-001-18 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 62558-001-18 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 62558-001-18 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 62558-001-18 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 62558-001-18 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 62558-001-18 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 62558-001-18 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 62558-001-18 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 62558-001-18 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 62558-001-18 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 62558-001-18 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 62558-001-18 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 62558-001-18 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 62558-001-18 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 62558-001-18 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 62558-001-18 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 62558-001-18 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 62558-001-18 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 62558-001-18 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 62558-001-18 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 62558-001-18 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 62558-001-18 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 62558-001-18 Doctor Manzanilla Cough Suppressant and Nasal Decongestant 118 mL in 1 BOTTLE SOLUTION 118 2 62558-001-18 Doctor Manzanilla Cough Suppressant and Nasal Decongestant 1 in 1 CARTON SOLUTION 1 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 DOCTOR MANZANILLA COUGH SUPPRESSANT AND NASAL DECONGESTANT (DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [MID VALLEY PHARMACEUTICALS LLC] 2 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ DOCTOR MANZANILLA COUGH SUPPRESSANT AND NASAL DECONGESTANT (DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [MID VALLEY PHARMACEUTICALS LLC] 2 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M DOCTOR MANZANILLA COUGH SUPPRESSANT AND NASAL DECONGESTANT (DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [MID VALLEY PHARMACEUTICALS LLC] 2 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV DOCTOR MANZANILLA COUGH SUPPRESSANT AND NASAL DECONGESTANT (DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [MID VALLEY PHARMACEUTICALS LLC] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP DOCTOR MANZANILLA COUGH SUPPRESSANT AND NASAL DECONGESTANT (DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [MID VALLEY PHARMACEUTICALS LLC] 2 EDETATE SODIUM INACTIVE INGREDIENT MP1J8420LU DOCTOR MANZANILLA COUGH SUPPRESSANT AND NASAL DECONGESTANT (DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [MID VALLEY PHARMACEUTICALS LLC] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX DOCTOR MANZANILLA COUGH SUPPRESSANT AND NASAL DECONGESTANT (DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [MID VALLEY PHARMACEUTICALS LLC] 2 PROPYL GALLATE INACTIVE INGREDIENT 8D4SNN7V92 DOCTOR MANZANILLA COUGH SUPPRESSANT AND NASAL DECONGESTANT (DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [MID VALLEY PHARMACEUTICALS LLC] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DOCTOR MANZANILLA COUGH SUPPRESSANT AND NASAL DECONGESTANT (DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [MID VALLEY PHARMACEUTICALS LLC] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU DOCTOR MANZANILLA COUGH SUPPRESSANT AND NASAL DECONGESTANT (DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [MID VALLEY PHARMACEUTICALS LLC] 2 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR DOCTOR MANZANILLA COUGH SUPPRESSANT AND NASAL DECONGESTANT (DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [MID VALLEY PHARMACEUTICALS LLC] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R DOCTOR MANZANILLA COUGH SUPPRESSANT AND NASAL DECONGESTANT (DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [MID VALLEY PHARMACEUTICALS LLC] 2 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 DOCTOR MANZANILLA COUGH SUPPRESSANT AND NASAL DECONGESTANT (DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [MID VALLEY PHARMACEUTICALS LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62558-001 DOCTOR MANZANILLA COUGH SUPPRESSANT AND NASAL DECONGESTANT (DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [MID VALLEY PHARMACEUTICALS LLC] 2 Legacy NDC, 2 package rows 20150717_8dcd4966-5cd0-485a-8543-07ebb1247634.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 62558-001-18 62558000118 118 mL in 1 BOTTLE 118 ml Historical