Acetaminophen Dextromethorphan HBr Guaifenesin Phenylephrine HCl

Product NDC
70692-133
11-digit product format
706920133
Labeler code
70692
Product ID
70692-133_b3b2e3fb-9370-7079-e053-2995a90afea1
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen Dextromethorphan HBr Guaifenesin Phenylephrine HCl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Strive Pharmaceuticals Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-07-10
Marketing end
0000-00-00
Substance
PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
5 mg/1; mg/1; mg/1; mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70692-133-82Acetaminophen Dextromethorphan HBr Guaifenesin Phenylephrine HCl8 in 1 PACKAGETABLET, COATED82

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70692-133ACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL TABLET, COATED [STRIVE PHARMACEUTICALS INC.]2Legacy NDC, 1 package rows20201110_97a2f1a0-f0d6-5778-e053-2995a90a16d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1110988acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN97a2f1a0-f0d6-5778-e053-2995a90a16d72
1110988acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD97a2f1a0-f0d6-5778-e053-2995a90a16d72
1110988APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY97a2f1a0-f0d6-5778-e053-2995a90a16d72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70692-133-82706920133828 TABLET, COATED in 1 PACKAGE (70692-133-82) 2019-07-100000-00-00NoNoCurrent