Awake

Product NDC: 21130-944
11-digit product format: 211300944
Labeler code: 21130
Product ID: 21130-944_726d6827-f32d-447a-b61b-37e9ab4c9550
Type: HUMAN OTC DRUG
Nonproprietary name: Caffeine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Better Living Brands, LLC
Application: M011
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1998-04-14
Substance: CAFFEINE
Active strength: 200 mg/1
Pharmacologic classes: Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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: Awake
Brand name suffix: Maximum Strength
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CAFFEINE	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3G6A5W338E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198520	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ce4da457-805f-4d2a-8667-6516eea85221	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
2dc76302-91c0-4c35-ad78-99adfb049c4b	Product name	1	20200603
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
e6065d4b-5ae1-476f-a40e-f2851cbb5d2b	Product name	2	20180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6	Product name	2	20161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
96c2be53-8e44-452d-56a2-d255b2f1af2d	Product name	1	20140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44	Product name	1	20140508
d223c173-c39b-d764-47d4-d671d3088815	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21130-944-11	AwakeMaximum Strength	60 in 1 BOTTLE	TABLET, FILM COATED	60		13
21130-944-11	AwakeMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1		13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CAFFEINE	ACTIVE INGREDIENT	3G6A5W338E	AWAKE MAXIMUM STRENGTH (CAFFEINE) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	1
CAFFEINE	ACTIVE MOIETY	3G6A5W338E	AWAKE MAXIMUM STRENGTH (CAFFEINE) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AWAKE MAXIMUM STRENGTH (CAFFEINE) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	AWAKE MAXIMUM STRENGTH (CAFFEINE) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AWAKE MAXIMUM STRENGTH (CAFFEINE) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	AWAKE MAXIMUM STRENGTH (CAFFEINE) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AWAKE MAXIMUM STRENGTH (CAFFEINE) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	AWAKE MAXIMUM STRENGTH (CAFFEINE) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21130-944	AWAKE MAXIMUM STRENGTH (CAFFEINE) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	12	Current NDC, Legacy NDC, 2 package rows	20250512_ce4da457-805f-4d2a-8667-6516eea85221.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 3 of 3 · 46 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stay Awake	CAFFEINE	AAA Pharmaceutical, Inc.	14967dc9-d223-d954-e063-6394a90aa676	2024-06-13	Warnings	Exact identifier application number: M011
JET ALERT Regular Strength	CAFFEINE	Bell Pharmaceuticals, Inc	cd7366f9-6ee9-4f1d-bfd2-3ce067f59b2d	2023-12-15	Warnings	Exact identifier application number: M011
Sleep Aid	DIPHENHYDRAMINE HCL	Allegiant Health	9746911a-36bc-45eb-adfd-e96439d7a865	2021-08-30	Warnings	Exact identifier application number: M011
Topcare Stay Awake Maximum Strength	CAFFEINE	TopCo Associates, LLC	2223cf52-c172-462d-aacc-b069849b7441	2021-04-28	Warnings	Exact identifier application number: M011
Stay Awake	CAFFEINE	Allegiant Health	959b50a1-3037-4f94-8bc5-651501815092	2019-01-08	Warnings	Exact identifier application number: M011
Stay Awake	CAFFEINE	Marc Glassman, Inc.	fda5b0a8-2c85-4a8b-97ab-777682c816e2	2016-12-21	Warnings	Exact identifier application number: M011

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3G6A5W338E	CAFFEINE	58-08-2	CAFFEINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198520	caffeine 200 MG Oral Tablet	PSN	ce4da457-805f-4d2a-8667-6516eea85221	13
198520	caffeine 200 MG Oral Tablet	SCD	ce4da457-805f-4d2a-8667-6516eea85221	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
21130-944-11	21130094411	1 BOTTLE in 1 CARTON (21130-944-11) / 60 TABLET, FILM COATED in 1 BOTTLE	1 bottle	1998-04-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Signature Select 44-344	Better Living Brands, LLC \| LNK International, Inc.	2026-01-21	HUMAN OTC DRUG LABEL	13